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
NCT ID: NCT01483742
Last Updated: 2016-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2012-04-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combination without RO5024048
Ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients
danoprevir
100 mg orally bid, 24 weeks
peginterferon alfa-2a [Pegasys]
180 mcg weekly, 24 weeks
ribavirin
1000-1200 mg/kg/day orally in two divided doses, 24 weeks
ritonavir
100 mg orally bid, 24 weeks
Combination with RO5024048
RO5024048 added to the combination treatment (ritonavir-boosted danoprevir in combination with Pegasys \[peginterferon alfa-2a\] and ribavirin) in prior null responder patients
RO5024048
1000 mg orally bid, 24 weeks
danoprevir
100 mg orally bid, 24 weeks
peginterferon alfa-2a [Pegasys]
180 mcg weekly, 24 weeks
ribavirin
1000-1200 mg/kg/day orally in two divided doses, 24 weeks
ritonavir
100 mg orally bid, 24 weeks
Interventions
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RO5024048
1000 mg orally bid, 24 weeks
danoprevir
100 mg orally bid, 24 weeks
peginterferon alfa-2a [Pegasys]
180 mcg weekly, 24 weeks
ribavirin
1000-1200 mg/kg/day orally in two divided doses, 24 weeks
ritonavir
100 mg orally bid, 24 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Anaheim, California, United States
Coronado, California, United States
La Jolla, California, United States
Long Beach, California, United States
DeLand, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Hillsborough, New Jersey, United States
New York, New York, United States
San Antonio, Texas, United States
Fitzroy, South Australia, Australia
Melbourne, Victoria, Australia
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Montpellier, , France
Auckland, , New Zealand
Christchurch, , New Zealand
Chorzów, , Poland
Mysłowice, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bratislava, , Slovakia
Countries
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Other Identifiers
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2011-004129-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NP27946
Identifier Type: -
Identifier Source: org_study_id
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