Brief Summary
This project is a retrospective (beginning January 2006) and prospective patient registry program sponsored by Ipsen (formerly Tercica, Inc.). In collaboration with participating health care practitioners, the patient registry program is an observational study monitoring the long-term safety of patients treated with Increlex® (mecasermin \[rDNA origin\] injection). The IGFD (Increlex® Growth Forum Database) Registry is intended primarily to monitor the safety and efficacy of Increlex replacement therapy in children with growth failure.
Brief Title
IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
Detailed Description
The data collected for a patient will be those that exist in the patient's medical record as part of standard medical care. No additional patient procedures or activities are mandated by this study. The specific data to be collected at each visit and the schedule of data collection are listed in a schedule of assessments.
The collection of safety events is considered essential to the Registry. The website will provide the opportunity to report the occurrence of targeted adverse events (AEs), other important events considered to be related to Increlex administration and serious adverse events (SAEs).
The collection of safety events is considered essential to the Registry. The website will provide the opportunity to report the occurrence of targeted adverse events (AEs), other important events considered to be related to Increlex administration and serious adverse events (SAEs).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Primary Insulin-like Growth Factor-1 Deficiency
Eligibility Criteria
Inclusion Criteria:
* Parents or legally authorized representatives must give signed informed consent before any Registry-related activities are conducted. Assent from the subject should also be obtained where appropriate.
* Patients receiving Increlex® by a qualified practitioner may be enrolled
Exclusion Criteria:
* Parents or legally authorized representatives must give signed informed consent before any Registry-related activities are conducted. Assent from the subject should also be obtained where appropriate.
* Patients receiving Increlex® by a qualified practitioner may be enrolled
Exclusion Criteria:
Inclusion Criteria
Inclusion Criteria:
* Parents or legally authorized representatives must give signed informed consent before any Registry-related activities are conducted. Assent from the subject should also be obtained where appropriate.
* Patients receiving Increlex® by a qualified practitioner may be enrolled
* Parents or legally authorized representatives must give signed informed consent before any Registry-related activities are conducted. Assent from the subject should also be obtained where appropriate.
* Patients receiving Increlex® by a qualified practitioner may be enrolled
Gender
All
Gender Based
false
Keywords
Growth Hormone (GH) Insensitivity Syndrome
Insulin-like Growth Factor Deficiency (IGFD)
Short Stature
Insulin-like Growth Factor (IGF-1)
Growth
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT00747604
Org Class
Industry
Org Full Name
Ipsen
Org Study Id
W-TG-52800-010 (MS305)
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
Primary Outcomes
Outcome Measure
To obtain long-term safety and efficacy data for Increlex® replacement therapy in children with growth failure
Outcome Time Frame
periodically assessed over the course of the study
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex.
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)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ping Zhou
Investigator Email
PZHOU@montefiore.org
Investigator Phone