Status:
COMPLETED
Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Genotype-1 Chronic HCV Infection
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Male or female, ages 18 to 65 years
- Documented chronic HCV infection, genotype 1a or 1b
- Treatment-naïve
- BMI = 18 - 35 kg/m2
Exclusion
- 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;
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00782353
Start Date
October 1 2008
End Date
March 1 2009
Last Update
November 14 2012
Active Locations (4)
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1
United States, Missouri
St Louis, Missouri, United States, 63104
2
United States, New York
New York, New York, United States, 10021
3
United States, Texas
San Antonio, Texas, United States, 78215
4
Puerto Rico, Santurce
Santurce, Puerto Rico, 00909