IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
|Primary Insulin-like Growth Factor-1 Deficiency||Biological: mecasermin [rDNA origin] injection|
|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|
- To obtain long-term safety and efficacy data for Increlex® replacement therapy in children with growth failure [ Time Frame: periodically assessed over the course of the study ]
|Study Start Date:||June 2006|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
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: Increlex®
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747604
|United States, New Jersey|
|Ipsen Central Contact|
|Basking Ridge, New Jersey, United States, 07920|
|Study Director:||Medical Director, Endocrinology||Ipsen (formerly Tercica)|