A study of the safety, efficacy, and tolerability of combination treatment of setrobuvir, danoprevir, ritonavir, and Copegus® with or without mericitabine in patients infected with the Hepatitis C virus who never received treatment before

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

• Males and Females at least 18 years of age at the time of dosing.
• Naive to treatment for HCV with interferon (pegylated or non pegylated). Patients who have participated in studies investigating a DAA with or without IFN are excluded.
• Evidence of CHC infection greater than or equal to 6 months duration at Screening Visit. Hepatitis C genotype 1 infection by molecular assay the Siemens VERSANT HCV Genotype Test, version 2.0 and serum HCV RNA quantifiable at more or equal to 50,000 IU/mL at the Screening Visit
• Liver biopsy or non-invasive (e.g., Fibroscan) evaluation in the past 24 calendar months showing absence of cirrhosis or incomplete/transition to cirrhosis using one of the scoring methods in Appendix 1. Patients with cirrhosis or incomplete/transition to cirrhosis will be excluded from this study.
• All female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective non-hormonal contraception (combined; i.e., condoms, cervical barriers, inter-uterine device (IUD), spermicides, or sponge), one of which must be a physical barrier method, during treatment and 6 months (or per local label if longer) post following the last dose of treatment. A hormonal contraception (in lieu of non-hormonal) plus a physical barrier method can be used two weeks after completion of study drug treatment.
• Body mass index (BMI) between 18 and 35, inclusive, and a minimum weight of 45 kg.
Signed, written informed consent, which must be obtained from the patient before any study-specific procedures are performed

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

- Pregnant or lactating women or males with female partners who are pregnant or lactating
- Decompensated liver disease or impaired liver function (as defined by protocol)
- Cirrhosis or incomplete/transition to cirrhosis
- Non- hepatitis C chronic liver disease
- Positive for hepatitis B or HIV infection
- History of pre-existing renal disease
- History of severe cardiac disease
- History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
- History of drug abuse within the last year; history of cannabinoid use is not excluded
- Evidence of alcohol abuse within 1 year of screening and consumption of more than 2 units of alcohol per day
- Medical condition that requires use of systemic corticosteroids
- Received warfarin or other anticoagulants during the 21 days immediately prior to screening or is expected to require warfarin or other anticoagulants during the study
- Anticipated use or need for significant medical treatment during the study or use of concomitant medications or nutrients that are excluded by protocol (e.g. drugs that are contraindicated with ritonavir, hormonal methods of contraception)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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