Status:
COMPLETED
A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve patients will be randomized...
Eligibility Criteria
Inclusion
- Adult patients, 18 to 65 years of age inclusive
- Documented chronic hepatitis C
- Treatment-naïve (no prior exposure to Pegasys, Copegus, or experimental HCV therapy) or treatment-experienced with current standard of care (Pegasys and Copegus) but categorized as null-responder or patients with partial response, relapse or viral breakthrough during or following prior treatment
- Serum HCV RNA \>/= 50,000 IU/mL at screening
- HCV antibody positive at screening
- HCV genotype 1
- Body mass index (BMI) 18-38 kg/m2
- In good health other than chronic HCV infection in the judgment of the principal investigators
- Negative for hepatitis B and HIV infection
Exclusion
- Pregnant or breastfeeding women
- For treatment-naïve patients: any previous treatment for HCV infection
- For treatment-experienced patients: previous treatment with an experimental therapy for HCV infection
- Co-infection with HIV or hepatitis C virus (HBV)
- History or evidence of decompensated liver disease
- History or evidence of hepatocellular carcinoma
- History of alcohol abuse and/or other drug addiction \</= 1 year prior to enrollment in the study
- Poorly controlled diabetes mellitus
- One or more additional known primary causes of liver disease other than hepatitis C
- History of acute or chronic pancreatitis
- Participation in an other clinical study of a new chemical entity within 30 days prior to study randomization
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT01903954
Start Date
January 1 2011
End Date
May 1 2013
Last Update
November 2 2016
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.