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Long-Term Treatment With rhIGF-1 in GHIS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00571727
First Posted: December 12, 2007
Last Update Posted: September 30, 2015
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.
Collaborator:
University of Oklahoma
Information provided by (Responsible Party):
Ipsen
  Purpose
Long term study of the effects of dosing with rhIGF-1 on growth

Condition Intervention Phase
Growth Hormone Insensitivity Syndrome Drug: mecasermin Phase 2 Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Change in height [ Time Frame: duration of study ]

Secondary Outcome Measures:
  • safety [ Time Frame: duration of study ]

Enrollment: 92
Study Start Date: January 1990
Study Completion Date: December 2011
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mecasermin, injections BID of rhIGF-1 Drug: mecasermin
injections BID of rhIGF-1, mecasermin
Other Name: Increlex

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00571727


Locations
United States, California
Ipsen
Brisbane, California, United States, 94005
Sponsors and Collaborators
Ipsen
University of Oklahoma
Investigators
Principal Investigator: Steven Chernausek, MD University of Oklahoma
  More Information

Publications:
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00571727     History of Changes
Other Study ID Numbers: Study 1419
First Submitted: December 10, 2007
First Posted: December 12, 2007
Last Update Posted: September 30, 2015
Last Verified: September 2015

Keywords provided by Ipsen:
growth
insulin like growth factor
Larons syndrome

Additional relevant MeSH terms:
Syndrome
Laron Syndrome
Disease
Pathologic Processes
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases