CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 92 enrolled
Drug / intervention
mecasermindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00571727
NCT00571727Phase 3Completed
CompareCT.gov

A Study of Long-Term Human Recombinant Insulin-Like Growth Factor-1 (rhIGF-1) in Children With Short Stature Due to Growth Hormone Insensitivity Syndrome (GHIS)

Ipsen·interventional·Posted Dec 12, 2007·Updated Jul 6, 2023

In Brief

A Phase 3 clinical trial evaluating mecasermin for Growth Hormone Insensitivity Syndrome. Completed, enrolled 92 participants across 1 site.

Detailed Summary

The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Insensitivity Syndrome
CountriesUnited States
CollaboratorsUniversity of Oklahoma

Timeline

Phase 3CompletedFinished
1991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 12, 2007
Enrollment StartMay 20, 1991
Primary CompletionDec 15, 2011
TodayJul 2, 2026
Enrollment to primary: 20.6 yearsPosted 18.6 years ago

Interventions

mecasermindrug

injections BID of rhIGF-1, mecasermin