Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Genotype-1 Chronic HCV Infection

Roche

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: ANA598 800 mg bid or placebo; Drug: ANA598 400 mg bid or placebo; Drug: ANA598 200 mg bid or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00782353

ANA598-502

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Subjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid

Treatment:

Drug: ANA598 200 mg bid or placebo

Cohort 2

Experimental group

Description:

Subjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid

Treatment:

Drug: ANA598 400 mg bid or placebo

Cohort 3

Experimental group

Description:

Subjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid

Treatment:

Drug: ANA598 800 mg bid or placebo