Evaluation of the Antiviral Pharmacodynamic Effect, Safety, and Pharmacokinetics of Escalating Doses of BILB 1941 ZW to Patients With Chronic Hepatitis C Genotype 1 Virus Infection

Exclusion Criteria

• •1. Males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation) in case their partner is of childbearing potential and is not using an adequate form of contraception (hormonal contraceptives, oral or injectable/implantable, intra-uterine device (IUD).
• •2. Any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis
• •3. Evidence of decompensated liver disease: ascites, portal hypertension or hepatic encephalopathy
• •4. Positive test for human immunodeficiency virus (HIV) or Hepatitis B surface (HBs) antigen at screening
• •5. Current alcohol or drug abuse, or history of the same, within the past twelve (12) months. All patients must abstain from alcohol from enrolment until completion of the study (visit 11).
• •6. Any concurrent medical illness or disease requiring treatment or concomitant medications
• •7. History of malignancy (except for previously cured squamous cell or basal cell carcinoma)
• •8. Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer; or the planned usage of an investigational drug during the course of the current study
• •9. Patients treated with interferon and/or ribavirin within 6 months prior to screening
• •10. Planned or concurrent usage of any other pharmacological therapy at screening, or during the trial period, including any antiviral therapy or vaccination
• •11. Known hypersensitivity to drugs or excipients
• •12. Patients with any one of the following laboratory values at screening:
• •* Alanine transaminase (ALT) or Aspartate transaminase (AST) \> 2.5 x upper limit of normal (ULN) (at screening and during the last 3 months before screening demonstrated by at least 2 further determinations)
• •* Total bilirubin \> 1x ULN
• •* Alkaline phosphatase \> 1.5x ULN
• •* Prothrombin time (INR, prolonged) \> 1.5
• •* Platelet count \< 100,000 / mm3
• •* Hemoglobin \< 10.5 g/dL
• •* White blood cell count \< 2,000 / mm3
• •13. Patients with any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
• •14. Positive urine test for drug abuse at screening
• •15. Patients with known Gilbert's disease
• •16. Prior randomisation to active treatment with BILB 1941 ZW into dose groups 3 - 9 of this trial, or previous re-treatment based on amendment 2. To support selection, centers will receive lists of the placebo patients of the previous dose levels, however, only for each center separately
• •17. Inability to comply with the protocol