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

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

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 ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.

Key facts

Study ID

NCT01483742

Run by

Hoffmann-La Roche

People needed

43

Starts

2012-04-01

Expected to finish

2013-09-01

Last updated by the study team

2016-08-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Anaheim, California, United States
• Study site — Coronado, California, United States
• Study site — La Jolla, California, United States
• Study site — Long Beach, California, United States
• Study site — DeLand, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Detroit, Michigan, United States
• Study site — Hillsborough, New Jersey, United States
• Study site — New York, New York, United States
• Study site — San Antonio, Texas, United States
• Study site — Fitzroy, South Australia, Australia
• Study site — Melbourne, Victoria, Australia
• Study site — Vancouver, British Columbia, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montpellier, France
• Study site — Auckland, New Zealand
• Study site — Christchurch, New Zealand
• Study site — Chorzów, Poland
• Study site — Mysłowice, Poland
• Study site — Warsaw, Poland

Full record on ClinicalTrials.gov

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