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IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome
NCT00368173 · View on ClinicalTrials.gov ↗
Study Summary
STUDY OBJECTIVE To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with GHIS. STUDY DESIGN This study is an open-label, multi-center clinical trial to evaluate the safety and effectiveness of rhIGF-I/rhIGFBP-3 to increase rate of growth when administered once daily for 12 months in children and adolescents with growth hormone insensitivity syndrome (GHIS) such as Laron Syndrome. At the end of the initial twelve-month treatment period, additional safety and long-term efficacy data will be assessed in a second 12 month treatment period.
Conditions Studied
Interventions
- DRUG rhIGF-I/rhIGFBP-3
Study Locations (15)
Other
- Dr. Alicia Belgorosky — Buenos Aires
- Dr. Christina Bazan — San Miguel de Tucumán
- Dr. Bruce King — Newcastle
- Dr. Durval Damiani — São Paulo
- Dr. Kwok-leung NG — Hong Kong
- Dr. Mohamed EL Kholy — Cairo
- Professor Annette Greuters — Berlin
- Tiosano Dov — Haifa
- Maria Carolina Salerno — Naples
- Dr. Hilde Bjorndalen — Oslo
- Dr. Carlos del Aguila — Lima
- Dr. Magdalena Paskova — Košice
- Professor Nursen Yordam — Ankara
- Dr. Cecilia Camacho-Hubner — London
New York
- Robert Rapaport, MD — New York
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00368173
The ClinicalTrials.gov registry entry for NCT00368173 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Insmed Incorporated, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Growth Hormone Insensitivity Syndrome (GHIS) appearing as the primary indexed condition, and to 1 intervention — of which rhIGF-I/rhIGFBP-3 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00368173 reports 15 study locations spanning 2 distinct geographic areas — top geographies include Other, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00368173 about?
NCT00368173 is a clinical study titled "IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome". STUDY OBJECTIVE To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with GHIS. STUDY DESIGN This study is an open-label, multi-center clinical trial to evaluate the safet...
What is the current status of trial NCT00368173?
This trial is currently completed. It is a Phase 2 study.
What conditions does trial NCT00368173 study?
This clinical trial studies the following conditions: Growth Hormone Insensitivity Syndrome (GHIS), Laron Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00368173?
The interventions under investigation include: rhIGF-I/rhIGFBP-3 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00368173?
This trial is sponsored by Insmed Incorporated, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00368173 being conducted?
This trial has 15 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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