Status:
COMPLETED
Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
Lead Sponsor:
Ipsen
Conditions:
Growth Disorders
Insulin-Like Growth Factor-1 Deficiency
Eligibility:
All Genders
3-12 years
Phase:
PHASE3
Brief Summary
This study is intended to determine whether twice daily weight based dosing with recombinant human insulin-like growth factor (rhIGF-1) will safely and effectively increase the growth of prepubertal c...
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 protoco...
Eligibility Criteria
Inclusion
- Chronological age ≥ 3 and chronological or bone age less than or equal to 11 years inclusive in girls;
- Chronological age ≥ 3 and chronological or bone age less than or equal to 12 years inclusive for boys
- Prepubertal
- Height SD score of \< -2
- IGF-1 SD score of \< -2
Exclusion
- Prior treatment with rhGH, rhIGF-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 :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00125164
Start Date
March 1 2004
End Date
July 1 2008
Last Update
September 18 2019
Active Locations (1)
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1
Ipsen (formerly Tercica)
Brisbane, California, United States, 94005