Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency - Full Text View

Sponsor:	Tercica
Information provided by:	Tercica
ClinicalTrials.gov Identifier:	NCT00125164

Purpose

This study is intended to determine whether dosing with recombinant human insulin-like growth factor (rhIGF-1) will safely and effectively increase the growth of prepubertal children with low IGF-1 levels but who produce sufficient growth hormone (GH). Subjects will be randomized to either an observation arm or to active treatment.

Condition	Intervention	Phase
Growth Disorders Insulin-Like Growth Factor-1 Deficiency	Drug: rhIGF-1 (mecasermin, Tercica, Inc.) for a period of 1 year	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Prepubertal Children With Growth Failure Associated With Primary IGF-1 Deficiency: A Phase 3, Randomized, Open Label, Observation-Controlled, Multicenter, Parallel-Dose Comparison Trial

Resource links provided by NLM:

MedlinePlus related topics: Growth Disorders

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

U.S. FDA Resources

Further study details as provided by Tercica:

Primary Outcome Measures:

Height velocity during the first year [ Time Frame: One year ] [ Designated as safety issue: No ]
Change in height standard deviation (SD) score [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in serum concentrations of IGF-1, IGF-2, insulin-like growth factor binding protein-2 (IGFBP-2) and insulin-like growth factor binding protein-3 (IGFBP-3) during the course of the study [ Time Frame: One year ] [ Designated as safety issue: No ]
Changes in bone age over one year [ Time Frame: One year ] [ Designated as safety issue: No ]
IGF generation test: serum IGF-1 and IGFBP-3 changes after 7 days exposure to recombinant human growth hormone (rhGH) [ Time Frame: Seven days ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	October 2004
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Observation: No Intervention
Dosed: Active Comparator IGF-1 dosing	Drug: rhIGF-1 (mecasermin, Tercica, Inc.) for a period of 1 year IGF-1 injections BID

Detailed Description:

Prepubertal growth failure associated with primary IGF-1 deficiency (IGFD). Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in GH action. In this protocol, primary IGFD is defined as short stature (<-2 standard deviations [SDs] below the mean for age and gender), abnormal serum IGF-1 (<-2 SDS below the mean for age and gender), and levels of growth hormone (GH) that are normal (≥7ng/mL) after a GH stimulation test. Primary IGFD is believed to result from a lower than normal ability to produce IGF-1 when exposed to normal levels of GH, i.e., a type of GH insensitivity of GH resistance.

This trial is a randomized, open label, observation-controlled, parallel-dose comparison efficacy and safety study conducted in approximately 40 centers across the United States.

Eligibility

Ages Eligible for Study:	3 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ages 3-10 years inclusive for girls; ages 3-11 years inclusive for boys
Prepubertal
Height SD score of < -2
IGF-1 SD score of < -2

Exclusion Criteria:

Prior treatment with GH, IGF-1, or other growth-influencing medications
Growth failure associated with other identifiable causes (e.g., syndromes, chromosomal abnormality)
Chronic illness such as diabetes, cystic fibrosis, etc.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125164

Locations

United States, California
Tercica, Inc.
Brisbane, California, United States, 94005

Sponsors and Collaborators

Tercica

Investigators

Study Director:

George Bright, M.D.

Tercica, Inc.

More Information

Additional Information:

Overview of clinical trial information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Tercica, Inc. ( Thorsten von Stein, M.D., PhD )
Study ID Numbers:	MS301
Study First Received:	July 27, 2005
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00125164 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tercica:

Primary IGF-1 Deficiency

Additional relevant MeSH terms:

Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Mitosis Modulators

Growth Disorders
Mitogens
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009