European Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The Eu-IGFD is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry. The purpose of this study is to collect long-term safety information on the use of recombinant DNA-derived human Insulin-like Growth Factor-1 (rhIGF-I) Increlex® replacement therapy for the treatment of children with growth failure.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Mecasermin

Criteria

Inclusion Criteria:

• All subjects beginning therapy with Increlex® or those previously treated with Increlex® by a participating qualified practitioner

• Parents or legally authorized representatives if applicable must give signed informed consent before any registry-related activities are conducted. Assent from the subject should also be obtained as appropriate

Exclusion Criteria:

• Subject currently participating in an Increlex® clinical trial

• Subject currently participating in any clinical trial for growth retardation