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

Conditions: Hepatitis C, Chronic

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


Eligibility criteria:
inclusion criteria: * female or male sex, age of 18 years or older * active, chronic hepatitis c virus (hcv) infection * liver biopsy consistent with active hcv infection obtained within the last 12 months * 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 (group 1, 2, 4 and 5) and non-genotype 1 (group 3) * hcv load greater than 50,000 copies messenger ribonucleic acid (mrna) per ml serum at screening * for group 5 only: histology showing moderate or severe fibrosis (portal fibrosis, septae, periportal and porto-central septae), no regenerative nodes and no incomplete or complete cirrhosis, corresponding to ishak score 3 or 4, or metavir f2 or f3 (if ishak is not 5) exclusion criteria: * women of childbearing potential or breastfeeding women. postmenopausal women less than 6 months after last menses, surgically sterilized or hysterectomised patients less than 3 months after operation or without a negative serum pregnancy test * males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation) if 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 * ascites or other current evidence of portal hypertension * histology showing signs of bridging or higher grade fibrosis (e.g. fibrosis \>= grade 3 (ishak score) or \>= 2 (metavir score) for treatment groups 1, 2, 3, 4 or for treatment group 5: histology showing less than moderate or severe fibrosis (portal fibrosis, septae, periportal and porto-central septae), or showing regenerative nodes or incomplete or complete cirrhosis, corresponding to other ishak scores than 3 or 4 and to other metavir scores than f2 or f3 (or f3 and ishak 5) * 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) * 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 randomization into this trial * child´s b or c liver diseases at screening (treatment groups 1, 2, 3, 4). applicable for treatment group 5 only: * for bilirubin - refer to following exclusion criterion * quick (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 (ap) exceeding 1.5 x upper limit of normal (uln) at screening (treatment groups 1, 2, 3, 4). treatment group 5 (biln 2061 zw, 200 mg bid/2 days in patients with advanced liver fibrosis): clinically apparent jaundice or a bilirubin \>= 2.0 mg/dl at screening. increased alkaline phosphatase (ap) is allowed. * alt or ast \> 5 x uln at screening (treatment groups 1, 2, 3, 4). treatment group 5: alt or ast \>= 10 x uln at screening * a platelet count of less than 100.000 platelets per mm3 at screening * white blood cell count of less than 2,000 cells per mm3 at screening * positive test for human immunodeficiency virus (hiv) at screening * 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