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NCT00368173 · ClinicalTrials.gov registry record · Phase 2
IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome
A Phase 2 study of Growth Hormone Insensitivity Syndrome (GHIS) and Laron Syndrome, sponsored by Insmed Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Study locations
NCT00368173: Completed Phase 2 study of Growth Hormone Insensitivity Syndrome (GHIS) and Laron Syndrome, sponsored by Insmed Incorporated.
NCT00368173 is a Phase 2 study of Growth Hormone Insensitivity Syndrome (GHIS) and Laron Syndrome that has completed, run by Insmed Incorporated. The trial reports 15 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00368173, a Phase 2 study of Growth Hormone Insensitivity Syndrome (GHIS) and Laron Syndrome, has completed, sponsored by Insmed Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. 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 31 total studies on file at ClinicalTrials.gov.
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.
NCT00368173 reports 15 study locations spanning 2 distinct geographic areas - top geographies include Other, New York.
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.
What interventions are being tested in trial NCT00368173?
The interventions under investigation include: rhIGF-I/rhIGFBP-3 (DRUG).
Who is sponsoring clinical trial NCT00368173?
This trial is sponsored by Insmed Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.
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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