Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype-1 Patients With Chronic HCV Infection

Hepatitis C Clinical Trial

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype 1 Patients With Chronic Hepatitis C Infection

Status Active, not recruiting

Clinical Trial Summary

Assess the safety and efficacy of ANA598 administered with Pegylated Interferon and Ribavirin in Genotype 1 Patients with Chronic Hepatitis C Infection.

Clinical Trial Description

Eligible patients with chronic hepatitis C infection (HCV genotype 1) will be randomized to treatment with 200 mg BID (total daily dose 400 mg) ANA598 or matching placebo, while receiving co-administered pegylated interferon and ribavirin (standard-of-care, SOC). All patients receiving ANA598 will receive a loading dose of 800 mg BID (total dose 1600 mg) on Day 1.

Treatment-Naïve Patients:

Enrollment will include approximately 133 treatment-naïve Genotype 1 patients with chronic HCV infection (100 randomized to receive ANA598 + SOC, and 33 randomized to receive matching placebo + SOC).

Treatment-naïve patients will be treated for either 28 weeks or 48 weeks, depending on response to treatment. Patients with undetectable HCV RNA at Week 8 and at subsequent visits will complete all treatment at Week 28.

Patients with Prior SOC Treatment (All will receive 48 Weeks of therapy):

Approximately 113 patients categorized as having prior relapse , prior partial response or prior viral breakthrough to previous treatment will be randomized to treatment with ANA598 200 mg BID + SOC or placebo + SOC (80 randomized to be treated with ANA598 + SOC, and 33 randomized to be treated with placebo + SOC).

Approximately 28 treatment-experienced patients categorized as null responders to previous treatment will be assigned treatment for 48 weeks with ANA598 200mg BID and co-administered pegylated interferon and ribavirin. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

• NCT number: NCT01281423
• Study type: Interventional
• Source: Hoffmann-La Roche
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 2010
• Completion date: May 2013