IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00747604|
Recruitment Status : Terminated (Shortage of Increlex supply)
First Posted : September 5, 2008
Last Update Posted : April 3, 2015
|Condition or disease||Intervention/treatment|
|Primary Insulin-like Growth Factor-1 Deficiency||Biological: mecasermin [rDNA origin] injection|
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).
|Study Type :||Observational|
|Actual Enrollment :||1378 participants|
|Official Title:||Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
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®
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747604
|United States, New Jersey|
|Ipsen Central Contact|
|Basking Ridge, New Jersey, United States, 07920|
|Study Director:||Medical Director, Endocrinology||Ipsen (formerly Tercica)|