IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome
NCT ID: NCT00368173
Last Updated: 2012-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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rhIGF-I/rhIGFBP-3
Eligibility Criteria
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Inclusion Criteria
2. 2 - 18 years of age,
3. Height less than or equal to -3SD for age,
4. Pre-pubertal, defined as Tanner breast stage 1 or testis volume \<4mL
Exclusion Criteria
2. Diagnosed malignancy,
3. A diagnosis of diabetes mellitus
2 Years
18 Years
ALL
No
Sponsors
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Insmed Incorporated
INDUSTRY
Locations
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Robert Rapaport, MD
New York, New York, United States
Dr. Alicia Belgorosky
Buenos Aires, , Argentina
Dr. Christina Bazan
San Miguel de Tucumán, , Argentina
Dr. Bruce King
Newcastle, , Australia
Dr. Durval Damiani
São Paulo, , Brazil
Dr. Kwok-leung NG
Hong Kong, , China
Dr. Mohamed EL Kholy
Cairo, , Egypt
Professor Annette Greuters
Berlin, , Germany
Tiosano Dov
Haifa, , Israel
Maria Carolina Salerno
Naples, , Italy
Dr. Hilde Bjorndalen
Oslo, , Norway
Dr. Carlos del Aguila
Lima, , Peru
Dr. Magdalena Paskova
Košice, , Slovakia
Professor Nursen Yordam
Ankara, , Turkey (Türkiye)
Dr. Cecilia Camacho-Hubner
London, , United Kingdom
Countries
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Other Identifiers
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INSM-110-303
Identifier Type: -
Identifier Source: org_study_id