Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency - Full Text View

Sponsor:	Tercica
Collaborator:	Ipsen
Information provided by:	Tercica
ClinicalTrials.gov Identifier:	NCT00125190

Purpose

This study is intended to assess the effects of once daily dosing of recombinant human insulin-like growth factor (rhIGF-1) in increasing height velocity.

Condition	Intervention	Phase
Insulin-Like Growth Factor-1 Deficiency Growth Disorders	Drug: rhIGF-1 (mecasermin) for a period of 86 weeks	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency: A Multi-Center, Open Label, Concentration-Controlled Study

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:

Increase in height velocity over the study period [ Time Frame: 34, 52 and 86 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in serum concentration of insulin-like growth factor binding-1 (IGFBP-1, IGFBP-2, IGFBP-3) and acid labile subunit (ALS) [ Time Frame: 34, 52 and 86 weeks ] [ Designated as safety issue: No ]
Changes in height standard deviation (SD) score over one year [ Time Frame: 34, 52 and 86 weeks ] [ Designated as safety issue: No ]
Changes in bone age over one year [ Time Frame: One year ] [ Designated as safety issue: No ]
rhIGF-1 doses required to achieve the serum IGF-1 targets with measures taken at each study visit [ Time Frame: 34, 52 and 86 weeks ] [ Designated as safety issue: No ]

Enrollment:	45
Study Start Date:	July 2005
Study Completion Date:	April 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

once a day rhIGF-1 injections

Detailed Description:

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 growth hormone (GH) action. In this protocol, primary IGFD is defined as short stature (<-2 standard deviations [SDs] below the mean for age and gender), and abnormal serum IGF-1 (<-2 SDs below the mean for age and gender).

The trial is an open-label, concentration-controlled trial conducted at up to 20 centers throughout the United States.

Eligibility

Ages Eligible for Study:	3 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronological age ≥ 3
Chronological age or bone age ≤ 12 for boys and ≤ 11 for girls
Prepubertal at Visit 1
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: NCT00125190

Locations

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

Sponsors and Collaborators

Tercica

Ipsen

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 ( Sandra Blethen, MD )
Study ID Numbers:	MS308
Study First Received:	July 27, 2005
Last Updated:	October 28, 2009
ClinicalTrials.gov Identifier:	NCT00125190 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tercica:

Primary IGF-1 Deficiency
IGF-1

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 27, 2009