Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosis

Medical University Graz,Department of Internal Medicine, Division of Gastroenterology and Hepatology0 个研究点目标入组 80 人开始时间: 2005年8月19日最近更新: 2013年5月20日

适应症

试验速览

暂无简介。

•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

发起方

Medical University Graz,Department of Internal Medicine, Division of Gastroenterology and Hepatology