Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients With Compensated Liver Cirrhosis

Inclusion criteria

• Patients with liver cirrhosis, that is histologically proven in a previous liver biopsy; possible aetiologies are: cured HCV infection, former alcohol abuse, genetic haemochromatosis, non-alcoholic steatohepatitis or others.
• Compensated liver disease, as indicated by Prothrombin time or INR prolonged to 3.5 g/dl, no ascites or encephalopathy (Child-Pugh grade A, score 1,7 x ULN, serum bilirubin > 2 mg/dl or albumin 5xULN, Alkaline Phosphatase > 2xULN
• Liver cirrhosis due to primary or secondary biliary cirrhosis, sclerosing cholangitis, vanishing bile duct disease
• History of alcohol abuse within the past 3 months
• Known hypersensitivity to any content of the study drug
• Pregnant or breast feeding females
• Females of childbearing potential who are not willing to ensure consistent and correct use of condoms and at least one additional medically accepted method of contraception (diaphragm with spermicidal substance, cervical caps) or who are unwilling to comply to complete abstinence, from the date of screening until 6 months after the last dose of study drug
• AFP value > 100 ng/ml; if AFP is > 20 and ULN)
• Haemoglobinopathy (e.g., thalassaemia major or sickle cell anaemia)
• Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the pharmacokinetic parameters or safety of the trial drug.
• Active or suspected malignancy or history of malignancy within the last 2 years (with the exception of appropriately treated basal cell carcinoma or in situ carcinoma of the uterine cervix)