A Phase 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 Insensitive Syndrome (GHIS) such a Laron Syndrome.
- Conditions
- Treatment of Growth Hormone Insensitivity Syndrome (GHIS) such as Laron Syndrome.MedDRA version: 6.1Level: PTClassification code 10005574
- Registration Number
- EUCTR2004-000644-25-IT
- Lead Sponsor
- INSMED INCORPORATED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method