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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00368173
Recruitment Status : Completed
First Posted : August 24, 2006
Last Update Posted : September 13, 2012
Information provided by:
Insmed Incorporated

Brief Summary:


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.


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 or disease Intervention/treatment Phase
Growth Hormone Insensitivity Syndrome (GHIS) Laron Syndrome Drug: rhIGF-I/rhIGFBP-3 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00368173

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United States, New York
Robert Rapaport, MD
New York, New York, United States
Dr. Alicia Belgorosky
Buenos Aires, Argentina
Dr. Christina Bazan
Tucuman, Argentina
Dr. Bruce King
Newcastle, Australia
Dr. Durval Damiani
Sao 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
Kosice, Slovakia
Professor Nursen Yordam
Ankara, Turkey
United Kingdom
Dr. Cecilia Camacho-Hubner
London, United Kingdom
Sponsors and Collaborators
Insmed Incorporated
Layout table for additonal information Identifier: NCT00368173    
Other Study ID Numbers: INSM-110-303
First Posted: August 24, 2006    Key Record Dates
Last Update Posted: September 13, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Laron Syndrome
Pathologic Processes
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases