Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosis
- Conditions
- Reduction of cardiovascular risk may become key for the management of PBC. Therefore information on safety and efficacy (lipid-lowering effects) of statins in chronic cholestatic disorders is essential. Moreover, the study will answer the open question whether long-term treatment with statins may have potential beneficial effects on the course of PBC.
- Registration Number
- EUCTR2005-002160-28-AT
- Lead Sponsor
- Medical University Graz,Department of Internal Medicine, Division of Gastroenterology and Hepatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion criteria (PBC):
LDL-cholesterol >= 130 mg/dl
Primary biliary cirrhosis (AMA positive or biopsy proven)
Male or female gender
Age 18-70 years
Normal kidney function
Inclusion criteria (non-PBC):
LDL-cholesterol >= 130 mg/dl matched for age, gender, glucose metabolism and vascular disease manifestations
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) yes
F.1.3.1 Number of subjects for this age range
Primary biliary cirrhosis Stage III-IV (Ludwig Score)
Liver cirrhosis
Decompensated liver disease ( > Child-Pugh class B, ascites, esophageal varices)
ALT or AST > 2x ULN
Pregnancy or breastfeeding
Premenopausal women without certain contraception
Known hypersensitivity to HMG-CoA reductase inhibitors
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