Long-Term Treatment With rhIGF-1 in GHIS

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Tercica Chernausek Steven MD The University of North Carolina at Chapel Hill Children's Hospital Medical Center, Cincinnati
Information provided by:	Tercica
ClinicalTrials.gov Identifier:	NCT00571727

Purpose

Long term study of the effects of dosing with rhIGF-1 on growth

Condition	Intervention	Phase
Growth Hormone Insensitivity Syndrome	Drug: mecasermin	Phase II Phase III

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Insulin Insulin-like growth factor I Mecasermin rinfabate Mecasermin Somatotropin Somatropin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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)

Further study details as provided by Tercica:

Primary Outcome Measures:

Change in height [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Enrollment:	76
Study Start Date:	January 1990
Estimated Study Completion Date:	January 2010

Intervention Details:

injections BID of rhIGF-1, mecasermin

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571727

Sponsors and Collaborators

Tercica

Chernausek Steven MD

The University of North Carolina at Chapel Hill

Children's Hospital Medical Center, Cincinnati

Investigators

Principal Investigator:

Steven Chernausek, MD

University of Oklahoma

More Information

Responsible Party:	Tercica, Inc ( Joyce Kuntze, Director )
Study ID Numbers:	Study 1419
Study First Received:	December 10, 2007
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00571727
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tercica:

growth
insulin like growth factor
Larons syndrome

Study placed in the following topic categories:

Laron-type dwarfism
Dwarfism
Genetic Diseases, Inborn
Musculoskeletal Diseases
Bone Diseases, Developmental

Laron Syndrome
Endocrine System Diseases
Endocrinopathy
Bone Diseases
Insulin

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 13, 2009