NCT00747604

IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex

Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,378 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Primary Insulin-like Growth Factor-1 Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	mecasermin [rDNA origin] injection	As prescribed by the physician.

Timeline

• Start date: 2006-06-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2008-09-05
• Last updated: 2020-11-06

Locations

1 site across 1 country: United States