Status:
COMPLETED
Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection
Lead Sponsor:
Hoffmann-La Roche
Conditions:
HCV Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 + S...
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...
Eligibility Criteria
Inclusion
- Male or female, ages 18 to 65 years
- Documented chronic HCV infection, genotype 1a or 1b
- Treatment-naïve
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00978497
Start Date
September 1 2009
End Date
August 1 2011
Last Update
March 31 2017
Active Locations (21)
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1
United States, California 1
Anaheim, California, United States, 92801
2
United States, California 4
Los Angeles, California, United States, 90048
3
United States, California 2
San Clemente, California, United States, 92673
4
United States, California 3
San Diego, California, United States, 92120