Clinical trial NCT02254707 (phase 1/phase 2, status: completed)
Conditions: hepatitis c, chronic
ICD codes: B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4
Drugs: bilb 1941 zw, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Adult males from 18 - 65 years

          2. Written informed consent consistent with ICH (International Conference on
             Harmonisation)/GCP (Good Clinical Practice) and local legislation given prior to any
             study procedures

          3. Chronic HCV infection demonstrated by positive HCV IgG Antibody

          4. HCV genotype 1 which has to be confirmed by central laboratory test before Visit 2

          5. Liver biopsy consistent with active Hepatitis C virus (HCV) infection obtained within
             the last 24 months showing minimal to mild liver fibrosis and without cirrhosis (Ishak
             or Metavir grade <= 2)

          6. HCV ribonucleic acid (RNA) load greater than 100,000 IU RNA per ml serum at screening

          7. Willing to abstain from alcohol during the screening, treatment and until completion
             of the study (visit 11)

        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