TerminatedNot Applicable

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

Stopped: Shortage of Increlex supply

United States1,378 participantsStarted 2006-06

Plain-language 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.

Who can participate

SexALL

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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:

What they're measuring

To obtain long-term safety and efficacy data for Increlex® replacement therapy in children with growth failure

Timeframe: periodically assessed over the course of the study

Trial details

NCT IDNCT00747604

SponsorIpsen

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-05

View on ClinicalTrials.gov More Primary Insulin-like Growth Factor-1 Deficiency trials