Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hepatitis C, Chronic
Eligibility:
MALE
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
To assess the antiviral effect, safety and pharmacokinetics of rising doses of 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 150 mg, 200 mg, 300 mg, 450 mg, 650 mg, 900 mg oral BILB 1941 ZW administered ...
Eligibility Criteria
Inclusion
- Adult males from 18 - 65 years
- Written informed consent consistent with ICH (International Conference on Harmonisation)/GCP (Good Clinical Practice) and local legislation given prior to any study procedures
- Chronic HCV infection demonstrated by positive HCV IgG Antibody
- HCV genotype 1 which has to be confirmed by central laboratory test before Visit 2
- 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)
- HCV ribonucleic acid (RNA) load greater than 100,000 IU RNA per ml serum at screening
- Willing to abstain from alcohol during the screening, treatment and until completion of the study (visit 11)
Exclusion
- 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).
- Any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis
- Evidence of decompensated liver disease: ascites, portal hypertension or hepatic encephalopathy
- Positive test for human immunodeficiency virus (HIV) or Hepatitis B surface (HBs) antigen at screening
- 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).
- Any concurrent medical illness or disease requiring treatment or concomitant medications
- 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 5 halflives, whichever is longer; or the planned usage of an investigational drug during the course of the current study
- Patients treated with interferon and/or ribavirin within 6 months prior to screening
- Planned or concurrent usage of any other pharmacological therapy at screening, or during the trial period, including any antiviral therapy or vaccination
- Known hypersensitivity to drugs or excipients
- 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
- Patients with any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
- Positive urine test for drug abuse at screening
- Patients with known Gilbert's disease
- 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
- Inability to comply with the protocol
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT02254707
Start Date
July 1 2004
Last Update
October 2 2014
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