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
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR and RO5024048 in Different Combinations in Null Responder or Treatment Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
2 other identifiers
interventional
43
7 countries
27
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2012
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
December 1, 2011
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedAugust 1, 2016
July 1, 2016
1.4 years
November 30, 2011
July 28, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Safety: Incidence of adverse events
48 weeks
Pharmacokinetics (PK): Area under the concentration-time curve (AUC)
Intensive PK sample collection during initial 2 week dosing period, followed by routine sampling during treatment up to Week 24
Antiviral activity: Hepatitis C virus (HCV) RNA levels assessed by Roche COBAS Taqman HCV Test
48 weeks
Secondary Outcomes (2)
Emergence of viral resistance: HCV RNA gene sequence variations
From baseline to Week 48
Virologic response: HCV RNA levels
approximately 1 year
Study Arms (2)
Combination without RO5024048
EXPERIMENTALRitonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients
Combination with RO5024048
EXPERIMENTALRO5024048 added to the combination treatment (ritonavir-boosted danoprevir in combination with Pegasys \[peginterferon alfa-2a\] and ribavirin) in prior null responder patients
Interventions
180 mcg weekly, 24 weeks
1000-1200 mg/kg/day orally in two divided doses, 24 weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Coronado, California, 92118, United States
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
Long Beach, California, 90807, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Orlando, Florida, 32803, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Atlanta, Georgia, 30309, United States
Unknown Facility
New Orleans, Louisiana, 70112, United States
Unknown Facility
Detroit, Michigan, 48202-2689, United States
Unknown Facility
Hillsborough, New Jersey, 08844, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
San Antonio, Texas, 78215, United States
Unknown Facility
Fitzroy, South Australia, 3065, Australia
Unknown Facility
Melbourne, Victoria, 3124, Australia
Unknown Facility
Vancouver, British Columbia, V6Z 2C7, Canada
Unknown Facility
Toronto, Ontario, M5G 2C4, Canada
Unknown Facility
Montpellier, 34094, France
Unknown Facility
Auckland, 1142, New Zealand
Unknown Facility
Christchurch, 8140, New Zealand
Unknown Facility
Chorzów, 41-500, Poland
Unknown Facility
Mysłowice, 41-400, Poland
Unknown Facility
Warsaw, 02-507, Poland
Unknown Facility
Wroclaw, 51-149, Poland
Unknown Facility
Bratislava, 833 05, Slovakia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2011
First Posted
December 1, 2011
Study Start
April 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
August 1, 2016
Record last verified: 2016-07