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Long-Term Treatment With rhIGF-1 in GHIS

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.
 
ClinicalTrials.gov Identifier: NCT00571727
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
University of Oklahoma
Information provided by (Responsible Party):
Ipsen

Study Description
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Brief Summary:
Long term study of the effects of dosing with rhIGF-1 on growth

Condition or disease Intervention/treatment Phase
Growth Hormone Insensitivity Syndrome Drug: mecasermin Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : January 1990
Actual Primary Completion Date : October 2004
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Mecasermin

Arms and Interventions
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Arm Intervention/treatment
Experimental: mecasermin, injections BID of rhIGF-1 Drug: mecasermin
injections BID of rhIGF-1, mecasermin
Other Name: Increlex


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

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

Eligibility Criteria
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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
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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
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United States, California
Ipsen
Brisbane, California, United States, 94005
Sponsors and Collaborators
Ipsen
University of Oklahoma
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Publications of Results:

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00571727    
Other Study ID Numbers: Study 1419
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Keywords provided by Ipsen:
growth
insulin like growth factor
Larons syndrome
Additional relevant MeSH terms:
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Laron Syndrome
Syndrome
Disease
Pathologic Processes
Dwarfism
Bone Diseases, Developmental
Bone Diseases
 Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Mecasermin
Growth Substances
Physiological Effects of Drugs