Long-Term Treatment With rhIGF-1 in GHIS

This study has been completed.
Sponsor:
Collaborator:
University of Oklahoma
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00571727
First received: December 10, 2007
Last updated: September 29, 2015
Last verified: September 2015
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: December 10, 2007
Last Updated: September 29, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 25, 2016