Status:
COMPLETED
Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
Lead Sponsor:
Ipsen
Conditions:
Insulin-Like Growth Factor-1 Deficiency
Growth Disorders
Eligibility:
All Genders
3+ years
Phase:
PHASE2
PHASE3
Brief 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.
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00125190
Start Date
July 1 2005
End Date
January 1 2009
Last Update
July 27 2020
Active Locations (1)
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1
Ipsen
Brisbane, California, United States, 94005