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NCT00572156 · ClinicalTrials.gov registry record · Phase 2
rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency
A Phase 2 study, sponsored by Ipsen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
NCT00572156: Clinical Trial Phase 2 study, sponsored by Ipsen.
NCT00572156 is a Phase 2 study that was terminated before completion, run by Ipsen. The registered enrollment target is 106 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00572156, a Phase 2 study, was terminated before completion, sponsored by Ipsen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
Study Summary
IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in response to another hormone called growth hormone. Growth Hormone is produced by a small gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors to growth during infancy, childhood, and adolescence. Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a type of growth hormone insensitivity and an inability to grow normally. This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will help children with IGFD grow taller more quickly than children treated with rhGH alone. The study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration (FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH in children with IGF-1 deficiency (IGFD) is investigational.
Interventions
- DRUG NutropinAq® (Somatropin [rDNA origin])
- DRUG Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2007-12 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
Why NCT00572156 stopped before completion
NCT00572156 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which NutropinAq® (Somatropin [rDNA origin]) is the first listed.
NCT00572156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00572156 about?
NCT00572156 is a clinical study titled "rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency". IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in response to another hormone called growth hormone. Growth Hormone is produced by a small gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors to growth during infancy, c...
What is the current status of trial NCT00572156?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2007-12. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00572156?
The interventions under investigation include: NutropinAq® (Somatropin [rDNA origin]) (DRUG), Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin]) (DRUG).
Who is sponsoring clinical trial NCT00572156?
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 NCT00572156's enrollment target sits among peer trials
106 648th of 2000 higher than 1,351 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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