A Study To Determine The Optimum Serum IGF-I Range In Patients With Acromegaly Treated With Pegvisomant - Optimum IGF1 in Acromegalic Patients on Pegvisomant
Phase 1
- Conditions
- AcromegalyMedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly
- Registration Number
- EUCTR2007-003741-33-GB
- Lead Sponsor
- Barts and the London NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Active acromegaly on pegvisomant monotherapy at a stable
dose with a normal age-adjusted serum IGF-I for at least 3
months
Over 18 years of age
Willing to provide informed consent
Are the trial subjects under 18? no
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
Unwilling or unable to provide informed consent
Other conditions known to alter IGF-I levels (severe hepatic
disease, severe renal disease, malnutrition, ethanol and drug
abuse)
Abnormal liver enzymes
Pregnancy/lactation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method