Status:
COMPLETED
Antiviral Efficacy, Pharmacokinetics and Safety of BILN 2061 ZW in Patients With Cirrhosis and Chronic Hepatitis C
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Liver Cirrhosis
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study to assess the antiviral efficacy, pharmacokinetics, and tolerability of 200 mg BILN 2061 ZW in a polyethylene glycol 400 (PEG 400: ethanol) drinking solution given orally for two days bid to pat...
Eligibility Criteria
Inclusion
- Female or male sex, age of 18 years or older
- Chronic Hepatitis C virus (HCV) infection
- Liver biopsy consistent with active HCV infection obtained within the last 36 months.
- No previous clinical evidence of decompensated cirrhosis. Present cirrhosis status consistent with grade A, according to Child-Turcotte-Pugh classification, confirmed at screening
- No evidence of significant gastroesophageal varices (\> grade 1 or other risk factors) according to fiberoptic endoscopy performed within the last 12 months
- No evidence of Hepatocellular carcinoma (HCC) by ultrasound performed at screening
- 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
- HCV load greater than 50,000 copies messenger ribonucleic acid (mRNA) per ml serum at screening
Exclusion
- Women of childbearing potential or breastfeeding women. Postmenopausal women less than 6 months after last menses, surgically sterilized or hysterectomised less than 3 months after operation or not having negative serum pregnancy test
- Males not using an adequate form of contraception (condom, sterilization at least 6 months post operation) in case 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
- Evidence of gastroesophageal varices
- Any histological evidence of hepatocytic dysplasia
- Following serological constellations: Hepatitis B surface (HBs)-Ag positive OR anti-Hepatitis B core (HBc) positive with anti- HBs negative OR anti-HAV IgM positive OR anti-Human immunodeficiency Virus (HIV) positive
- 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 of the skin)
- 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 or present Child´s B or C liver diseases -
- Bilirubin - refer to following exclusion criterion
- 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 exceeding 2.0 x upper limit of normal (ULN) at screening
- ALT or AST \>= 10 x ULN at screening
- A platelet count of less than 80.000 platelets per mm3 at screening
- White blood cell count of less than 2,000 cells per mm3 at screening
- AFP \> 100 ng/ml
- Splenectomy
- 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 :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02226939
Start Date
September 1 2002
Last Update
August 27 2014
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