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Long-Term Treatment With rhIGF-1 in GHIS

This study has been completed.
University of Oklahoma
Information provided by (Responsible Party):
Ipsen Identifier:
First received: December 10, 2007
Last updated: September 29, 2015
Last verified: September 2015
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


Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
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
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Please refer to this study by its identifier: NCT00571727

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

Responsible Party: Ipsen Identifier: NCT00571727     History of Changes
Other Study ID Numbers: Study 1419
Study First Received: December 10, 2007
Last Updated: September 29, 2015

Keywords provided by Ipsen:
insulin like growth factor
Larons syndrome

Additional relevant MeSH terms:
Laron Syndrome
Pathologic Processes
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases processed this record on August 21, 2017