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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 is a Phase 3 study that has completed, run by Ipsen. The registered enrollment target is 137 participants.

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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.

Interventions

  • DRUG rhIGF-1 (mecasermin, Tercica, Inc.)

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2004-03
Est. Completion 2008-07
Phase Phase 3

Sponsor

Ipsen

85 total trials

What the Registry Record Tells You About NCT00125164

The ClinicalTrials.gov registry entry for NCT00125164 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which rhIGF-1 (mecasermin, Tercica, Inc.) is the first listed.

NCT00125164 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.