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

September 11, 2012 updated by: Insmed Incorporated

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Insmed Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 23, 2006

First Submitted That Met QC Criteria

August 23, 2006

First Posted (Estimate)

August 24, 2006

Study Record Updates

Last Update Posted (Estimate)

September 13, 2012

Last Update Submitted That Met QC Criteria

September 11, 2012

Last Verified

September 1, 2012

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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