antiviral efficacy, pharmacokinetics and safety of biln 2061 zw in patients with cirrhosis and chronic hepatitis c

Conditions: Liver Cirrhosis; Hepatitis C, Chronic

Summary: study to assess the antiviral efficacy, pharmacokinetics, and tolerability of 200 mg biln 2061 zw in a polyethylene glycol 400 (peg 400: ethanol) drinking solution given orally for two days bid to patients with cirrhosis and chronic hepatitis c virus (hcv) infection


Eligibility criteria:
inclusion criteria: * female or male sex, age of 18 years or older * chronic hepatitis c virus (hcv) infection * liver biopsy consistent with active hcv infection obtained within the last 36 months. * no previous clinical evidence of decompensated cirrhosis. present cirrhosis status consistent with grade a, according to child-turcotte-pugh classification, confirmed at screening * no evidence of significant gastroesophageal varices (\> grade 1 or other risk factors) according to fiberoptic endoscopy performed within the last 12 months * no evidence of hepatocellular carcinoma (hcc) by ultrasound performed at screening * written informed consent consistent with international committee on harmonization (ich) / good clinical practice (gcp) and local legislation given prior to any study procedures * hcv of genotype i * hcv load greater than 50,000 copies messenger ribonucleic acid (mrna) per ml serum at screening exclusion criteria: * women of childbearing potential or breastfeeding women. postmenopausal women less than 6 months after last menses, surgically sterilized or hysterectomised less than 3 months after operation or not having negative serum pregnancy test * males not using an adequate form of contraception (condom, sterilization at least 6 months post operation) in case their partner is of childbearing potential (criteria see above) and is not using an adequate form of contraception (hormonal contraceptives, oral or injectable/ implantable, intra-uterine device (iud)) * any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis * evidence of gastroesophageal varices * any histological evidence of hepatocytic dysplasia * following serological constellations: hepatitis b surface (hbs)-ag positive or anti-hepatitis b core (hbc) positive with anti- hbs negative or anti-hav igm positive or anti-human immunodeficiency virus (hiv) positive * history of abuse of alcohol within the past twelve months * planned or concurrent usage of any other pharmacological therapy at screening, including any antiviral therapy * any concurrent infectious disease requiring antimicrobial treatment * history of malignancy (except for previously cured squamous cell or basal cell carcinoma of the skin) * usage of any investigational drug within thirty (30) days prior to enrolment; or the planned usage of an investigational drug during the course of the current study * known hypersensitivity to drugs * inability to comply with the protocol * prior or present child´s b or c liver diseases - * bilirubin - refer to following exclusion criterion * prothrombin time \< 70% * albumin \< 3.5 g/dl * clinical evidence of ascites * clinical evidence of encephalopathy * clinically apparent jaundice or a total bilirubin or alkaline phosphatase exceeding 2.0 x upper limit of normal (uln) at screening * alt or ast \>= 10 x uln at screening * a platelet count of less than 80.000 platelets per mm3 at screening * white blood cell count of less than 2,000 cells per mm3 at screening * afp \> 100 ng/ml * splenectomy * positive test for illicit or unprescribed drugs or medications at screening. positive test for cannabis may be allowed if the investigator assesses this result not as clinically significant * patients with any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening