A Phase II/III, Open-Label, Multi-Center Clinical Trial to Evaluate the Safety and Efficacy of Insulin-Like Growth Factor I/ Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3), Administered for 12 Months in Children and Adolescents with Growth Hormone Insensitivity Syndrome (GHIS) such as Laron Syndrome.
Phase 1
- Conditions
- Growth Hormone Insensitivity Syndrome (GHIS) is a genetically disturbance of the biological action of growth hormone (GH). This study is intended to evaluate the ability of rhIGF-I/rhIGFBP-3 to demonstrate height velocity increases, in pre-pubertal children with GHIS and to evaluate the safety profile of extended treatment with rhIGF-I/rhIGFBP-3, believed to be more favorable that that observed with rhIGF-I.
- Registration Number
- EUCTR2004-000644-25-SK
- Lead Sponsor
- Insmed Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
See protocol page 12.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
See protocol page 12.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety, tolerability and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in prepubertal children and adolescents with GHIS. ;Secondary Objective: None.;Primary end point(s): Change in Height Velocity (HV) from baseline.
- Secondary Outcome Measures
Name Time Method