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| Sponsor: | Ipsen |
|---|---|
| Information provided by (Responsible Party): | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00747604 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Severe Primary Insulin-like Growth Factor-1 Deficiency |
Biological: mecasermin [rDNA origin] injection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex |
| Estimated Enrollment: | 2000 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | June 2020 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Increlex patients
Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex.
|
Biological: mecasermin [rDNA origin] injection
As prescribed by the physician.
Other Name: Severe Primary IGFD
|
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 AEs, other important events considered to be related to Increlex administration and serious adverse events (SAEs).
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ipsen Central Contact | clinical.trials@ipsen.com |
| United States, New Jersey | |
| Ipsen Central Contact | Recruiting |
| Basking Ridge, New Jersey, United States, 07920 | |
| Study Director: | Kathleen Lomax, M.D. | Ipsen (formerly Tercica) |
More Information
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00747604 History of Changes |
| Other Study ID Numbers: | MS305 |
| Study First Received: | September 3, 2008 |
| Last Updated: | April 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
GH Insensitivity Syndrome Insulin-like Growth Factor Deficiency Short Stature IGF-1 Growth |
