NCT00978497

Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Trial of the Safety, Efficacy, and Pharmacokinetics of ANA598 Administered With Pegylated Interferon and Ribavirin in Treatment-Naïve Genotype 1 Patients With Chronic Hepatitis C Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (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 assess the safety, tolerability and effectiveness of ANA598 when administered with pegylated interferon and ribavirin (Standard of Care \[SOC\]) compared to placebo + SOC.

Detailed description

The safety, tolerability and antiviral activity of ANA598, administered orally at 200 mg BID or 400 mg BID for 12 weeks in combination with pegylated interferon and ribavirin (SOC) will be compared to placebo + SOC. Treatment-naïve patients with genotype 1 infection will be eligible for enrollment. Patients randomized to ANA598 will receive a loading dose of 800 mg q 12 hours administered on the first day of dosing. Patients with undetectable HCV RNA at week 4 and week 12 will be randomized to receive either an additional 12 or 36 weeks of SOC alone. Ninety patients will be randomized into 2 cohorts. The forty-five patients in each cohort will be randomized as 30 active: 15 placebo.

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	placebo	oral BID
DRUG	ANA598	oral 200mg BID
DRUG	ANA598	oral 400mg BID
DRUG	Peginterferon	180 μg dose via subcutaneous injection weekly
DRUG	Ribavirin	oral 1000 mg/day for patients who weighed \< 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-04-01
• Completion: 2011-08-01
• First posted: 2009-09-17
• Last updated: 2017-03-31

Locations

21 sites across 2 countries: United States, Puerto Rico