Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection
- Conditions
- HCV Infection
- Interventions
- Registration Number
- NCT00978497
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
- Male or female, ages 18 to 65 years
- Documented chronic HCV infection, genotype 1a or 1b
- Treatment-naïve
- Female patients who are pregnant or breast-feeding
- Infection with non-genotype 1 HCV
- Previous treatment for HCV infection
- HIV or HBV positive
- Any medical contraindication to Peg-IFN or RBV therapy
- History of any other known cause of liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 ANA598 ANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks 1 Peginterferon Peginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks 1 placebo Peginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks 2 Peginterferon ANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks 3 Peginterferon ANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks 3 ANA598 ANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks 1 Ribavirin Peginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks 2 Ribavirin ANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks 3 Ribavirin ANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks
- Primary Outcome Measures
Name Time Method Undetectable HCV RNA 12 Weeks
- Secondary Outcome Measures
Name Time Method Safety and Tolerability Throughout study ANA598, Peg-IFN-a-2-a, ribavirin concentrations Various time points through Week 12 Undetectable HCV RNA 24 weeks after completion of therapy for sustained virologic response [SVR]
Trial Locations
- Locations (20)
United States, New York
🇺🇸New York, New York, United States
United States, Maryland
🇺🇸Lutherville, Maryland, United States
United States, California 2
🇺🇸San Clemente, California, United States
United States, California 3
🇺🇸San Diego, California, United States
United States, California 1
🇺🇸Anaheim, California, United States
United States, Florida 1
🇺🇸Sarasota, Florida, United States
United States, California 4
🇺🇸Los Angeles, California, United States
United States, California 5
🇺🇸San Francisco, California, United States
United States, Florida 3
🇺🇸Miami, Florida, United States
United States, Texas 2
🇺🇸Houston, Texas, United States
United States, Massachusetts
🇺🇸Boston, Massachusetts, United States
United States, Michigan
🇺🇸Detroit, Michigan, United States
United States, Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
United States, Texas 1
🇺🇸San Antonio, Texas, United States
United States, Virginia 1
🇺🇸Fairfax, Virginia, United States
United States, Florida 2
🇺🇸Gainesville, Florida, United States
Puerto Rico
🇵🇷Santurce, Puerto Rico
United States, North Carolina
🇺🇸Durham, North Carolina, United States
United States, Ohio
🇺🇸Cincinnati, Ohio, United States
United States, Virginia 2
🇺🇸Falls Church, Virginia, United States