IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/27/2013 |
| Start Date: | May 2006 |
| End Date: | December 2020 |
| Contact: | Ipsen Central Contact |
| Email: | clinical.trials@ipsen.com |
Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
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.
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).
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:
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