Status:
COMPLETED
Antiviral Efficacy, Pharmacokinetics and Safety of BILN 2061 ZW in Patients With Chronic Hepatitis C Virus Infection
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 chron...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT02226952
Start Date
November 1 2001
Last Update
August 27 2014
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