Brief Summary
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients \< 4 months of age.
Brief Title
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
Categories
Completion Date
Completion Date Type
Actual
Conditions
Cytomegalovirus Infections, Heart Transplantation
Eligibility Criteria
Inclusion Criteria:
* Males and females, 0 to \< 4 months (\< 125 days) of age at the time of the last PK assessment in this study
* Parent or guardian of the patient is willing and able to give written informed consent
* Patient has received a first heart transplant
* Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV
* Adequate hematological and renal function
* Able to tolerate oral medication (any appropriate form of tube feeding is acceptable)
Exclusion Criteria:
* Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
* Severe, uncontrolled, clinically abnormal diarrhea
* Liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT)
* Patient requires use of any protocol prohibited concomitant medications
* Patient has previously participated in this clinical trial
* Males and females, 0 to \< 4 months (\< 125 days) of age at the time of the last PK assessment in this study
* Parent or guardian of the patient is willing and able to give written informed consent
* Patient has received a first heart transplant
* Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV
* Adequate hematological and renal function
* Able to tolerate oral medication (any appropriate form of tube feeding is acceptable)
Exclusion Criteria:
* Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
* Severe, uncontrolled, clinically abnormal diarrhea
* Liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT)
* Patient requires use of any protocol prohibited concomitant medications
* Patient has previously participated in this clinical trial
Inclusion Criteria
Inclusion Criteria:
* Males and females, 0 to \< 4 months (\< 125 days) of age at the time of the last PK assessment in this study
* Parent or guardian of the patient is willing and able to give written informed consent
* Patient has received a first heart transplant
* Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV
* Adequate hematological and renal function
* Able to tolerate oral medication (any appropriate form of tube feeding is acceptable)
* Males and females, 0 to \< 4 months (\< 125 days) of age at the time of the last PK assessment in this study
* Parent or guardian of the patient is willing and able to give written informed consent
* Patient has received a first heart transplant
* Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV
* Adequate hematological and renal function
* Able to tolerate oral medication (any appropriate form of tube feeding is acceptable)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
124 Days
NCT Id
NCT01165580
Org Class
Industry
Org Full Name
Hoffmann-La Roche
Org Study Id
NP22523
Overall Status
Completed
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age
Primary Outcomes
Outcome Measure
Area under plasma concentration versus time curve of ganciclovir
Outcome Time Frame
0, 1-3, 3-7, 7-12, 24 hours post-dose
Outcome Measure
Apparent volume of distribution of ganciclovir
Outcome Time Frame
0, 1-3, 3-7, 7-12, 24 hours post-dose
Outcome Measure
Terminal half-life of ganciclovir
Outcome Time Frame
0, 1-3, 3-7, 7-12, 24 hours post-dose
Outcome Measure
Peak concentration of ganciclovir
Outcome Time Frame
0, 1-3, 3-7, 7-12, 24 hours post-dose
Secondary Ids
Secondary Id
2010-021172-28
Secondary Outcomes
Outcome Time Frame
9 days
Outcome Measure
Safety (Incidence of adverse events)
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
0
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rebecca Madan
Investigator Email
rmadan@montefiore.org
Investigator Phone