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IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome

This study is ongoing, but not recruiting participants.

Sponsored by: Insmed
Information provided by: Insmed
ClinicalTrials.gov Identifier: NCT00368173
  Purpose

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.


Condition Intervention Phase
Growth Hormone Insensitivity Syndrome (GHIS)
Laron Syndrome
Drug: rhIGF-I/rhIGFBP-3
Phase II
Phase III

Genetics Home Reference related topics:   pseudoachondroplasia   

ChemIDplus related topics:   Insulin-like growth factor I    Mecasermin rinfabate    Somatotropin    Somatropin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
  Eligibility
Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

  1. A diagnosis of GHIS such as Laron syndrome,
  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:

  1. Children in puberty,
  2. Diagnosed malignancy,
  3. A diagnosis of diabetes mellitus
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368173

Locations
United States, New York
Robert Rapaport, MD    
      New York, New York, United States
Argentina
Dr. Christina Bazan    
      Tucuman, Argentina
Dr. Alicia Belgorosky    
      Buenos Aires, Argentina
Australia
Dr. Bruce King    
      Newcastle, Australia
Brazil
Dr. Durval Damiani    
      Sao Paulo, Brazil
China
Dr. Kwok-leung NG    
      Hong Kong, China
Egypt
Dr. Mohamed EL Kholy    
      Cairo, Egypt
Germany
Professor Annette Greuters    
      Berlin, Germany
Israel
Tiosano Dov    
      Haifa, Israel
Italy
Maria Carolina Salerno    
      Naples, Italy
Norway
Dr. Hilde Bjorndalen    
      Oslo, Norway
Peru
Dr. Carlos del Aguila    
      Lima, Peru
Slovakia
Dr. Magdalena Paskova    
      Kosice, Slovakia
Turkey
Professor Nursen Yordam    
      Ankara, Turkey
United Kingdom
Dr. Cecilia Camacho-Hubner    
      London, United Kingdom

Sponsors and Collaborators
Insmed
  More Information


Study ID Numbers:   INSM-110-303
First Received:   August 23, 2006
Last Updated:   March 29, 2007
ClinicalTrials.gov Identifier:   NCT00368173
Health Authority:   United States: Food and Drug Administration;   Germany: Federal Institute for Drugs and Medical Devices;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Turkey: Ministry of Health;   Israel: Ministry of Health

Study placed in the following topic categories:
Laron-type dwarfism
Dwarfism
Genetic Diseases, Inborn
Musculoskeletal Diseases
Bone Diseases, Developmental
Laron Syndrome
Endocrine System Diseases
Endocrinopathy
Bone Diseases

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on October 10, 2008




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