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

Phase 1

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: ANA598 200 mg bid or placebo; Drug: ANA598 400 mg bid or placebo; Drug: ANA598 800 mg bid or placebo

• Registration Number: NCT00782353
• Lead Sponsor: Hoffmann-La Roche

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-28
• Study First Submitted QC: 2008-10-29
• Study First Posted: 2008-10-31
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-12
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	ANA598 200 mg bid or placebo	Subjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid
Cohort 2	ANA598 400 mg bid or placebo	Subjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid
Cohort 3	ANA598 800 mg bid or placebo	Subjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

United States, Missouri; 🇺🇸 St. Louis, Missouri, United States

United States, New York; 🇺🇸 New York, New York, United States

Puerto Rico, Santurce; 🇵🇷 Santurce, Puerto Rico

United States, Texas; 🇺🇸 San Antonio, Texas, United States