Clareo Health | ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment
ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients, \>/= 18 years of age
Chronic hepatitis C genotype 1 of \>/= 6 months duration at screening
Part 1 and Part 2: Naïve to treatment with interferon (pegylated or non-pegylated). Patients who have participated in studies investigating a direct-acting antiviral agent with or without interferon are excluded
Part 2: Treatment experienced patients having a previous null response to treatment with interferon containing regimen
Liver biopsy or non-invasive (e.g. Fibroscan) evaluation in the past 24 calendar months showing absence of cirrhosis or incomplete/transition to cirrhosis
Body mass index (BMI) 18 to 35 kg/m2 inclusive and body weight \>/= 45 kg
You may not be if
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)
