Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
Information source: Tercica
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insulin-Like Growth Factor-1 Deficiency; Growth Disorders
Intervention: rhIGF-1 (mecasermin) for a period of 86 weeks (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Tercica Official(s) and/or principal investigator(s):
George Bright, M.D., Study Director, Affiliation: Tercica, Inc.
Summary
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Increase in height velocity over the study period
Secondary outcome: Changes in serum concentration of insulin-like growth factor binding-1 (IGFBP-1, IGFBP-2, IGFBP-3) and acid labile subunit (ALS)Changes in height standard deviation (SD) score over one year Changes in bone age over one year rhIGF-1 doses required to achieve the serum IGF-1 targets with measures taken at each study visit
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
Minimum age: 3 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Tercica, Inc., Brisbane, California 94005, United States
Additional Information
Overview of clinical trial information
Starting date: July 2005
Ending date: March 2009
Last updated: June 11, 2008
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