Status:
COMPLETED
A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavir...
Eligibility Criteria
Inclusion
- Adult patients, 18 to 65 years of age inclusive
- Chronic hepatitis C, genotype 1 or 4
- Cohort 1: Treatment-naïve for hepatitis C
- Cohort 2: Prior null responder to treatment with approved doses of pegylated interferon plus ribavirin
- Liver biopsy confirming cirrhosis
- Compensated cirrhosis (Child-Pugh A)
Exclusion
- Pregnant or lactating women or male partners of women who are pregnant
- History or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices)
- Cohort 2: Patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response
- History of clinically significant cardiovascular or cerebrovascular disease
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01483742
Start Date
April 1 2012
End Date
September 1 2013
Last Update
August 1 2016
Active Locations (27)
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1
Birmingham, Alabama, United States, 35294
2
Anaheim, California, United States, 92801
3
Coronado, California, United States, 92118
4
La Jolla, California, United States, 92037