Chronic Hepatitis C
Conditions
Keywords
HCV
Brief summary
The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.
Detailed description
The safety, tolerability and antiviral activity of ANA598, administered orally twice daily for 3 days, will be compared to placebo in treatment-naïve subjects chronically infected with HCV genotype 1 infection. Thirty (30) subjects will be randomized to one of three cohorts described above. The ten patients in each cohort will be randomized 8 active: 2 placebo. At least 5 subjects with genotype 1a and 5 subjects with genotype 1b will be enrolled within each cohort.
Interventions
DRUGANA598 200 mg bid or placebo
ANA598 200 mg bid or placebo
DRUGANA598 400 mg bid or placebo
ANA598 400 mg bid or placebo
DRUGANA598 800 mg bid or placebo
ANA598 800 mg bid or placebo
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, ages 18 to 65 years * Documented chronic HCV infection, genotype 1a or 1b * Treatment-naïve * BMI = 18 - 35 kg/m2
Exclusion criteria
* Female patients who are pregnant or breast-feeding * Previous treatment for HCV infection * HIV or HBV positive * Evidence of cirrhosis on previous liver biopsy or on previous imaging studies * History of any other known cause of liver disease;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease; | 10 days |
| The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels | 10 days |
Countries
Puerto Rico, United States
Outcome results
None listed