CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 137 enrolled
Drug / intervention
rhIGF-1 (mecasermin, Tercica, Inc.)drug
Likely dose
Mecasermin (rhIGF-1) twice daily injectionAI-extracted
Key inclusion· 5
  • ✓Chronological age ≥3 years
  • ✓Chronological or bone age ≤11 years for girls; ≤12 years for boys
  • ✓Prepubertal status
  • ✓Height SD score <-2
Key exclusion· 3
  • ✕Prior treatment with rhGH, rhIGF-1, or other growth-influencing medications
  • ✕Growth failure from secondary causes (syndromes, chromosomal abnormalities)
  • ✕Chronic illnesses such as diabetes or cystic fibrosis

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

Search/NCT00125164
NCT00125164Phase 3Completed
CompareCT.gov

Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Prepubertal Children With Growth Failure Associated With Primary IGF-1 Deficiency: A Phase 3, Randomized, Open Label, Observation-Controlled, Multicenter, Parallel-Dose Comparison Trial

Ipsen·interventional·Posted Jul 29, 2005·Updated Sep 18, 2019

In Brief

A Phase 3 clinical trial evaluating rhIGF-1 (mecasermin, Tercica, Inc.) for Growth Disorders and Insulin-Like Growth Factor-1 Deficiency. Completed, enrolled 137 participants across 1 site.

Detailed Summary

This study is intended to determine whether twice daily weight based dosing with recombinant human insulin-like growth factor (rhIGF-1) will safely and effectively increase the growth of prepubertal children with short stature associated with low IGF-1 levels but who produce sufficient growth hormone (GH). Subjects will be randomized to either an observation arm or to active treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Disorders, Insulin-Like Growth Factor-1 Deficiency
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2005
Enrollment StartMar 1, 2004
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.9 years ago

Interventions

rhIGF-1 (mecasermin, Tercica, Inc.)drug

Twice Daily Injection