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NCT00125164 · ClinicalTrials.gov registry record · Phase 3
Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
A Phase 3 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 137
- Enrollment target
NCT00125164: Completed Phase 3 study, sponsored by Ipsen.
NCT00125164 is a Phase 3 study that has completed, run by Ipsen. The registered enrollment target is 137 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00125164, a Phase 3 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 137 participants
- Enrollment target
Study 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.
Primary Outcome
Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.
Interventions
- DRUG rhIGF-1 (mecasermin, Tercica, Inc.)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2004-03 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
What the finished NCT00125164 record still lists
NCT00125164 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which rhIGF-1 (mecasermin, Tercica, Inc.) is the first listed.
NCT00125164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00125164 about?
NCT00125164 is a clinical study titled "Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency". 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 hormon...
What is the current status of trial NCT00125164?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 137 participants. The study started on 2004-03. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00125164?
The interventions under investigation include: rhIGF-1 (mecasermin, Tercica, Inc.) (DRUG).
Who is sponsoring clinical trial NCT00125164?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00125164's enrollment target sits among peer trials
137 1580th of 2000 higher than 421 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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