NCT00782353

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

A Phase 1, Randomized, Double-Blind, Ascending Multiple-Dose Study of the Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Chronic Hepatitis C Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	ANA598 200 mg bid or placebo	ANA598 200 mg bid or placebo
DRUG	ANA598 400 mg bid or placebo	ANA598 400 mg bid or placebo
DRUG	ANA598 800 mg bid or placebo	ANA598 800 mg bid or placebo

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-10-31
• Last updated: 2012-11-14

Locations

4 sites across 2 countries: United States, Puerto Rico