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

History of Changes

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:

Genetics Home Reference related topics: Laron syndrome Meier-Gorlin syndrome metatropic dysplasia pseudoachondroplasia

MedlinePlus related topics: Hormones

Drug Information available for: Mecasermin

Genetic and Rare Diseases Information Center resources: Laron Syndrome

U.S. FDA Resources

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:

Chernausek SD, Backeljauw PF, Frane J, Kuntze J, Underwood LE; GH Insensitivity Syndrome Collaborative Group. Long-term treatment with recombinant insulin-like growth factor (IGF)-I in children with severe IGF-I deficiency due to growth hormone insensitivity. J Clin Endocrinol Metab. 2007 Mar;92(3):902-10. Epub 2006 Dec 27.


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 September 23, 2016

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