IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome - Full Text View

IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome

This study is ongoing, but not recruiting participants.

Sponsored by:	Insmed
Information provided by:	Insmed
ClinicalTrials.gov Identifier:	NCT00368173

Purpose

STUDY OBJECTIVE

To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with GHIS.

STUDY DESIGN

This study is an open-label, multi-center clinical trial to evaluate the safety and effectiveness of rhIGF-I/rhIGFBP-3 to increase rate of growth when administered once daily for 12 months in children and adolescents with growth hormone insensitivity syndrome (GHIS) such as Laron Syndrome. At the end of the initial twelve-month treatment period, additional safety and long-term efficacy data will be assessed in a second 12 month treatment period.

Condition	Intervention	Phase
Growth Hormone Insensitivity Syndrome (GHIS) Laron Syndrome	Drug: rhIGF-I/rhIGFBP-3	Phase II Phase III

Genetics Home Reference related topics:

pseudoachondroplasia

ChemIDplus related topics:

Insulin-like growth factor I Mecasermin rinfabate Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

A diagnosis of GHIS such as Laron syndrome,
2 - 18 years of age,
Height less than or equal to -3SD for age,
Pre-pubertal, defined as Tanner breast stage 1 or testis volume <4mL

Exclusion Criteria:

Children in puberty,
Diagnosed malignancy,
A diagnosis of diabetes mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368173

Locations


United States, New York
	Robert Rapaport, MD
	New York, New York, United States

Argentina
	Dr. Christina Bazan
	Tucuman, Argentina
	Dr. Alicia Belgorosky
	Buenos Aires, Argentina

Australia
	Dr. Bruce King
	Newcastle, Australia

Brazil
	Dr. Durval Damiani
	Sao Paulo, Brazil

China
	Dr. Kwok-leung NG
	Hong Kong, China

Egypt
	Dr. Mohamed EL Kholy
	Cairo, Egypt

Germany
	Professor Annette Greuters
	Berlin, Germany

Israel
	Tiosano Dov
	Haifa, Israel

Italy
	Maria Carolina Salerno
	Naples, Italy

Norway
	Dr. Hilde Bjorndalen
	Oslo, Norway

Peru
	Dr. Carlos del Aguila
	Lima, Peru

Slovakia
	Dr. Magdalena Paskova
	Kosice, Slovakia

Turkey
	Professor Nursen Yordam
	Ankara, Turkey

United Kingdom
	Dr. Cecilia Camacho-Hubner
	London, United Kingdom

Sponsors and Collaborators

Insmed

More Information

Study ID Numbers:	INSM-110-303
First Received:	August 23, 2006
Last Updated:	March 29, 2007
ClinicalTrials.gov Identifier:	NCT00368173
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Turkey: Ministry of Health; Israel: Ministry of Health

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

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on October 10, 2008