Clincosm LogoSign in Get a demo

Long-Term Treatment With rhIGF-1 in GHIS

Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT00571727
Collaborator
University of Oklahoma (Other)
92
Enrollment
1
Location
1
Arm
263
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Long term study of the effects of dosing with rhIGF-1 on growth

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study of the Long-Term Human Recombinant Insulin-Like Growth Factor-1 (rhIGF-1) Treatment in Children With Short Stature Due to Growth Hormone Insensitivity Syndrome (GHIS)
Study Start Date :
Jan 1, 1990
Actual Primary Completion Date :
Oct 1, 2004
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: mecasermin, injections BID of rhIGF-1

Drug: mecasermin
injections BID of rhIGF-1, mecasermin
Other Names:
  • Increlex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in height [duration of study]

    Secondary Outcome Measures

    1. safety [duration of study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Height <-2SD for age and gender

    • IGF-1 <-2SD for age and gender

    • Evidence of GH resistance

    Exclusion Criteria:

    • closed epiphyses

    • prior active malignancy

    • major organ disfunction

    • treatment with medications that would diminish growth

    • clinically significant cardiac abnormalities

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ipsen Brisbane California United States 94005

    Sponsors and Collaborators

    • Ipsen
    • University of Oklahoma

    Investigators

    • Study Director: Ipsen Medical Director, Ipsen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ipsen
    ClinicalTrials.gov Identifier:
    NCT00571727
    Other Study ID Numbers:
    • Study 1419
    First Posted:
    Dec 12, 2007
    Last Update Posted:
    Jan 7, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Ipsen
    growth
    insulin like growth factor
    Larons syndrome
    Additional relevant MeSH terms:
    Laron Syndrome
    Syndrome
    Mecasermin

    Study Results

    No Results Posted as of Jan 7, 2019