- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00368173
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 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.
Study Overview
Status
Intervention / Treatment
Study Type
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
- Dr. Alicia Belgorosky
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Tucuman, Argentina
- Dr. Christina Bazan
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Newcastle, Australia
- Dr. Bruce King
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Sao Paulo, Brazil
- Dr. Durval Damiani
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Hong Kong, China
- Dr. Kwok-leung NG
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Cairo, Egypt
- Dr. Mohamed EL Kholy
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Berlin, Germany
- Professor Annette Greuters
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Haifa, Israel
- Tiosano Dov
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Naples, Italy
- Maria Carolina Salerno
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Oslo, Norway
- Dr. Hilde Bjorndalen
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Lima, Peru
- Dr. Carlos del Aguila
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Kosice, Slovakia
- Dr. Magdalena Paskova
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Ankara, Turkey
- Professor Nursen Yordam
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London, United Kingdom
- Dr. Cecilia Camacho-Hubner
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New York
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New York, New York, United States
- Robert Rapaport, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A diagnosis of GHIS such as Laron syndrome,
- 2 - 18 years of age,
- Height less than or equal to -3SD for age,
- Pre-pubertal, defined as Tanner breast stage 1 or testis volume <4mL
Exclusion Criteria:
- Children in puberty,
- Diagnosed malignancy,
- A diagnosis of diabetes mellitus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INSM-110-303
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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