Status:
COMPLETED
Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Are Non-responders to Previous Treatment (MK-7009-045)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
20-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir (300 mg twice daily) given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Japanese participant diagnosed with compensated CHC GT 1
- Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease
- Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN) with or without use of ribavirin, but failed to respond to the prior treatment (partial responder or null responder)
- No evidence of cirrhosis
- Exclusion criteria:
- Co-infection with human immunodeficiency virus (HIV)
- Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
- Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
- Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant
Exclusion
Key Trial Info
Start Date :
September 2 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01405560
Start Date
September 2 2011
End Date
March 29 2013
Last Update
October 18 2018
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