Brief Summary
The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).
Brief Title
Phase 2/3 Study of IGSC, 20% in PIDD
Completion Date
Completion Date Type
Actual
Conditions
Primary Immunodeficiency Diseases (PID)
Eligibility Criteria
Main Inclusion Criteria:
* Documented diagnosis of a form of primary humoral immunodeficiency involving defective antibody formation and requiring gammaglobulin replacement as defined according to the IUIS Scientific Committee, 2011 and by diagnostic criteria according to Conley et al. (1999). The diagnosis must be confirmed by the Medical Director prior to first treatment with the investigational product (IP) in the study.
* Participant is 2 years or older at the time of screening, and has a minimum body weight of 13 kg.
* Written informed consent has been obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration
* Participant has been receiving a stable monthly equivalent dose of IgG at an average minimum dose equivalent to 300 mg/kg bodyweight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks, for a minimum of 12 weeks prior to first treatment with the IP in the study.
* Serum trough level of IgG \> 500 mg/dL at screening
* Participant is willing and able to comply with the requirements of the protocol
Main Exclusion Criteria:
* Participant has known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for Hepatitis C virus(HCV), PCR for human immunodeficiency virus (HIV) Type 1/2
* Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):
* Persistent alanine aminotransferase (ALT) and aspartate amino transferase(AST) \> 2.5 times the upper limit of normal for the testing laboratory
* Persistent severe neutropenia (defined as an absolute neutrophil count \[ANC\] ≤500/mm\^3)
* Creatinine clearance (CLcr) value that is \< 60% of normal for age and gender either measured, or calculated according to the Cockcroft-Gault formula
* Malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years
* Participant is receiving anti-coagulation therapy (low dose aspirin at ≤325 mg/day is permitted) or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) or sickle cell disease with crisis within 12 months prior to screening or a history of thrombophilia
* Abnormal protein loss (protein losing enteropathy, nephrotic syndrome)
* Anemia that would preclude phlebotomy for laboratory studies according to standard practice at the site
* Acute serious bacterial infection within 3 months prior to screening
* Ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following intravenous immunoglobulin, subcutaneous immunoglobulin, and/or Immune Serum Globulin (ISG) infusions
* Severe immunoglobulin A (IgA) deficiency (less than 0.07g/L) with known anti-IgA antibodies and a history of hypersensitivity
* Participant is on continuous systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and, in the opinion of the investigator, cannot stop these for the duration of the study without putting the patient at risk of increased infections
* Participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening
* Bleeding disorder or thrombocytopenia with a platelet count less than 20,000/μL, or who, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of subcutaneous therapy
* Total protein \> 9 g/dL or myeloma or macroglobulinemia (IgM) or paraproteinemia
* Severe dermatitis that would preclude adequate sites for safe product administration
* Women of childbearing potential meeting any one of the following criteria:
* Participant presents with a positive pregnancy test
* Participant is breast feeding
* Participant intends to begin nursing during the course of the study
* Participant does not agree to employ adequate birth-control measures (e.g. intrauterine device, diaphragm or condom \[for male partner\] with spermicidal jelly or foam, or birth control pills/patches) throughout the course of the study
* Participation in another clinical study and exposure to an investigational product or device within 30 days prior to study enrollment (exception: treatment in a previous Baxter immunoglobulin study)
* Participant is scheduled to participate in another (non-Baxter) non-observational (interventional) clinical study involving an investigational product or device during the course of the study
* Documented diagnosis of a form of primary humoral immunodeficiency involving defective antibody formation and requiring gammaglobulin replacement as defined according to the IUIS Scientific Committee, 2011 and by diagnostic criteria according to Conley et al. (1999). The diagnosis must be confirmed by the Medical Director prior to first treatment with the investigational product (IP) in the study.
* Participant is 2 years or older at the time of screening, and has a minimum body weight of 13 kg.
* Written informed consent has been obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration
* Participant has been receiving a stable monthly equivalent dose of IgG at an average minimum dose equivalent to 300 mg/kg bodyweight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks, for a minimum of 12 weeks prior to first treatment with the IP in the study.
* Serum trough level of IgG \> 500 mg/dL at screening
* Participant is willing and able to comply with the requirements of the protocol
Main Exclusion Criteria:
* Participant has known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for Hepatitis C virus(HCV), PCR for human immunodeficiency virus (HIV) Type 1/2
* Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):
* Persistent alanine aminotransferase (ALT) and aspartate amino transferase(AST) \> 2.5 times the upper limit of normal for the testing laboratory
* Persistent severe neutropenia (defined as an absolute neutrophil count \[ANC\] ≤500/mm\^3)
* Creatinine clearance (CLcr) value that is \< 60% of normal for age and gender either measured, or calculated according to the Cockcroft-Gault formula
* Malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years
* Participant is receiving anti-coagulation therapy (low dose aspirin at ≤325 mg/day is permitted) or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) or sickle cell disease with crisis within 12 months prior to screening or a history of thrombophilia
* Abnormal protein loss (protein losing enteropathy, nephrotic syndrome)
* Anemia that would preclude phlebotomy for laboratory studies according to standard practice at the site
* Acute serious bacterial infection within 3 months prior to screening
* Ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following intravenous immunoglobulin, subcutaneous immunoglobulin, and/or Immune Serum Globulin (ISG) infusions
* Severe immunoglobulin A (IgA) deficiency (less than 0.07g/L) with known anti-IgA antibodies and a history of hypersensitivity
* Participant is on continuous systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and, in the opinion of the investigator, cannot stop these for the duration of the study without putting the patient at risk of increased infections
* Participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening
* Bleeding disorder or thrombocytopenia with a platelet count less than 20,000/μL, or who, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of subcutaneous therapy
* Total protein \> 9 g/dL or myeloma or macroglobulinemia (IgM) or paraproteinemia
* Severe dermatitis that would preclude adequate sites for safe product administration
* Women of childbearing potential meeting any one of the following criteria:
* Participant presents with a positive pregnancy test
* Participant is breast feeding
* Participant intends to begin nursing during the course of the study
* Participant does not agree to employ adequate birth-control measures (e.g. intrauterine device, diaphragm or condom \[for male partner\] with spermicidal jelly or foam, or birth control pills/patches) throughout the course of the study
* Participation in another clinical study and exposure to an investigational product or device within 30 days prior to study enrollment (exception: treatment in a previous Baxter immunoglobulin study)
* Participant is scheduled to participate in another (non-Baxter) non-observational (interventional) clinical study involving an investigational product or device during the course of the study
Inclusion Criteria
Inclusion Criteria:
* Documented diagnosis of a form of primary humoral immunodeficiency involving defective antibody formation and requiring gammaglobulin replacement as defined according to the IUIS Scientific Committee, 2011 and by diagnostic criteria according to Conley et al. (1999). The diagnosis must be confirmed by the Medical Director prior to first treatment with the investigational product (IP) in the study.
* Participant is 2 years or older at the time of screening, and has a minimum body weight of 13 kg.
* Written informed consent has been obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration
* Participant has been receiving a stable monthly equivalent dose of IgG at an average minimum dose equivalent to 300 mg/kg bodyweight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks, for a minimum of 12 weeks prior to first treatment with the IP in the study.
* Serum trough level of IgG \> 500 mg/dL at screening
* Participant is willing and able to comply with the requirements of the protocol
* Documented diagnosis of a form of primary humoral immunodeficiency involving defective antibody formation and requiring gammaglobulin replacement as defined according to the IUIS Scientific Committee, 2011 and by diagnostic criteria according to Conley et al. (1999). The diagnosis must be confirmed by the Medical Director prior to first treatment with the investigational product (IP) in the study.
* Participant is 2 years or older at the time of screening, and has a minimum body weight of 13 kg.
* Written informed consent has been obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration
* Participant has been receiving a stable monthly equivalent dose of IgG at an average minimum dose equivalent to 300 mg/kg bodyweight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks, for a minimum of 12 weeks prior to first treatment with the IP in the study.
* Serum trough level of IgG \> 500 mg/dL at screening
* Participant is willing and able to comply with the requirements of the protocol
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
2 Years
NCT Id
NCT01218438
Org Class
Industry
Org Full Name
Takeda
Org Study Id
170904
Overall Status
Completed
Phases
Phase 2
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)
Primary Outcomes
Outcome Description
Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit.
Outcome Measure
Rate of Acute Serious Bacterial Infections Per Year (ASBI)
Outcome Time Frame
1 year
Secondary Outcomes
Outcome Time Frame
1 year
Outcome Measure
Annual Rate of All Infections Per Participant
Outcome Time Frame
1 year
Outcome Measure
Annual Rate of Sinus Infections Per Participant
Outcome Time Frame
1 year
Outcome Measure
Annual Rate of Fever Episodes Per Participant
Outcome Time Frame
1 year
Outcome Measure
Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant
Outcome Time Frame
1 year
Outcome Measure
Annual Rate of Days on Antibiotics Per Participant
Outcome Time Frame
1 year
Outcome Measure
Annual Rate of Hospitalizations for Illness or Infection Per Participant
Outcome Time Frame
1 year
Outcome Measure
Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant
Outcome Time Frame
1 year
Outcome Measure
Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant
Outcome Description
IGSC, 20% = Immune Globulin Subcutaneous (Human), 20% Solution; AUCSC = area under the concentration-time curve following subcutaneous administration; AUCIV,0-τ = area under the concentration-time curve following intravenous administration over a dosing interval
Outcome Time Frame
Epoch 1: 3 week IV administration interval: Week 10, 11, 12, 13. Epoch 1: 4 week IV interval: Week 9, 10, 11, 12, 13. Epoch 4 Subcutaneous administration weeks 17, 18
Outcome Measure
Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old)
Outcome Time Frame
Epoch 1: 3 week IV interval- weeks 0, 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 0, 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)
Outcome Measure
Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals
Outcome Time Frame
Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)
Outcome Measure
Trough Levels of Anti-Tetanus Antibody
Outcome Time Frame
Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)
Outcome Measure
Trough Levels of Anti-Haemophilus Influenza B Antibody
Outcome Time Frame
Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)
Outcome Measure
Trough Levels of Anti-Hepatitis B Antibody
Outcome Description
The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week)
Outcome Time Frame
Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Outcome Measure
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC)
Outcome Description
The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.
Outcome Time Frame
Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Outcome Measure
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC)
Outcome Description
Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0-τ). (F= bioavailability)
Outcome Time Frame
Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Outcome Measure
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC)
Outcome Description
The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).
Outcome Time Frame
Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Outcome Measure
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax)
Outcome Description
The minimum time (Tmax) to reach the maximum concentration (Cmax)
Outcome Time Frame
Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Outcome Measure
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax)
Outcome Description
The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).
Outcome Time Frame
Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Outcome Measure
Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin)
Outcome Description
The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week )
Outcome Time Frame
Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Outcome Measure
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC)
Outcome Description
The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.
Outcome Time Frame
Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Outcome Measure
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC)
Outcome Description
Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0- τ). (F= bioavailability)
Outcome Time Frame
Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Outcome Measure
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously
Outcome Description
The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).
Outcome Time Frame
Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Outcome Measure
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax)
Outcome Description
The minimum time (Tmax) to reach the maximum concentration (Cmax)
Outcome Time Frame
Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Outcome Measure
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax)
Outcome Description
The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).
Outcome Time Frame
Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Outcome Measure
Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin)
Outcome Description
There is a high degree of variability in catabolism of immunoglobulin G (IgG) between individuals. To address this, trough levels immediately prior to the 9th weekly infusion in Epoch 3 were measured. The ratio of the measured trough levels on subcutaneous (SC) (Epoch 3) and intravenous (IV) administration (Epoch1) were compared to the expected trough level determined in Epoch 2. This was used to determine the Individually Adapted Dose to be used in Epoch 4. This was an interim study analysis.
Outcome Time Frame
29 weeks
Outcome Measure
Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table)
Outcome Description
Number of related SAEs and AEs divided by number of participants
Outcome Time Frame
Up to 20 months per subject (throughout entire study)
Outcome Measure
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant
Outcome Description
Number of related SAEs and AEs divided by number of subjects and divided by number of infusions
Outcome Time Frame
Up to 20 months per subject (throughout entire study)
Outcome Measure
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion
Outcome Description
Number of all SAEs and AEs divided by number of participants
Outcome Time Frame
Up to 20 months per subject (throughout entire study)
Outcome Measure
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant
Outcome Description
Number of all SAEs and AEs divided by number of infusions
Outcome Time Frame
Up to 20 months per subject (throughout entire study)
Outcome Measure
Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion
Outcome Description
Number of AEs that begin during or within 72 hours of completion of infusion divided by number of participants
Outcome Time Frame
Within 72 hours of completion of infusion
Outcome Measure
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant
Outcome Description
Number of AEs that begin during or within 72 hours of completion of infusion divided by the number of infusions
Outcome Time Frame
Within 72 hours of completion of infusion
Outcome Measure
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion
Outcome Description
Number of AEs that begin during or within 24 hours of completion of infusion divided by number of participants
Outcome Time Frame
Within 24 hours of completion of infusion
Outcome Measure
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant
Outcome Description
Number of AEs that begin during or within 24 hours of completion of infusion divided by number of infusions
Outcome Time Frame
Within 24 hours of completion of infusion
Outcome Measure
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion
Outcome Description
Number of AEs that begin during or within 1 hour of completion of infusion divided by number of participants
Outcome Time Frame
Within 1 hour of completion of infusion
Outcome Measure
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant
Outcome Description
Number of AEs that begin during or within 1 hour of completion of infusion divided by number of infusions
Outcome Time Frame
Within 1 hour of completion of infusion
Outcome Measure
Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion
Outcome Description
The total number of all AEs (including and excluding infections) that begin during infusion or within 72 hours of completion of an infusion ("temporally associated") plus the total number of AEs (including and excluding infections) starting more than 72 hours following the completion of an infusion determined by the investigator to be at least possibly related to the study drug("related"), divided by the total number of infusions
Outcome Time Frame
Within 72 hours post infusion for Temporally Associated AEs; End of each Study Epoch (Epoch 1, Epoch 2, Epoch 3, and Epoch 4) for Causally Related AEs
Outcome Measure
Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion
Outcome Description
The number of infusions associated with local non-SAEs divided by the total number of infusions.
Outcome Time Frame
Up to 20 months (throughout entire study)
Outcome Measure
Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs)
Outcome Time Frame
Up to 20 months (throughout entire study)
Outcome Measure
Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs)
Outcome Time Frame
Up to 20 months (throughout entire study)
Outcome Measure
Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs
Outcome Time Frame
Up to 20 months (throughout entire study)
Outcome Measure
Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs
Outcome Description
An infusion will be deemed as tolerated unless one of the following occurs: 1. Any serious related AE(s) 2. Any non-serious local or systemic related AE(s) that prevent(s) completion of infusion 3. Any severe non-serious local or systemic related AE(s) that occur within 60 minutes of completion of the infusion
Outcome Time Frame
Up to 20 months (throughout entire study)
Outcome Measure
Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Outcome Description
Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. \*Note 5th Grade (grade 0) added to scale to reflect within normal range.
Outcome Time Frame
Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Outcome Measure
Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Outcome Description
Laboratory tests for confirmation of potential hemolysis include Coomb's test, haptoglobin, free hemoglobin, reticulocyte count, lactate dehydrogenase (LDH), and urine hemosiderin.
Outcome Time Frame
Epoch 1: 3 week IV interval- weeks 0, 10. Epoch 1: 4 week IV interval- weeks 0, 9. Epoch 3: Subcutaneous (SC) week 9. Epoch 4: SC weeks 17, 18, 40
Outcome Measure
Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration
Outcome Description
The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \& school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.
Outcome Time Frame
Up to 20 months (throughout entire study)
Outcome Measure
Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years
Outcome Description
The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \& school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.
Outcome Time Frame
Up to 20 months (throughout entire study)
Outcome Measure
Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age
Outcome Description
The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores.
Outcome Time Frame
Up to 20 months (throughout entire study)
Outcome Measure
Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older
Outcome Description
TSQM; for the age group 2 to 12 years the observer will be a parent. Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.
Outcome Time Frame
Up to 20 months per subject (throughout entire study)
Outcome Measure
Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old
Outcome Description
TSQM; for the age group 13 years and older the observer will be the participant. Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.
Outcome Time Frame
Up to 20 months per subject (throughout entire study)
Outcome Measure
Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older
Outcome Description
For the age group 2 to 12 years the respondent will be a parent. Each of the four domains has a separate score, each has a different range as follows: Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment.
Outcome Time Frame
Up to 20 months (throughout entire study)
Outcome Measure
Life Quality Index - 2 to 12 Years Old
Outcome Description
For the age group 13 years and older the respondent will be the participant. Each of the four domains has a separate score, each has a different range as follows: Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment.
Outcome Time Frame
Up to 20 months per subject (throughout entire study)
Outcome Measure
Life Quality Index - 13 Years and Older
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Arye Rubinstein
Investigator Email
arye.rubinstein@einsteinmed.org
Investigator Phone