A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection
A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio
2 other identifiers
interventional
229
6 countries
40
Brief Summary
This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2009
40 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
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedNovember 2, 2016
November 1, 2016
2.4 years
August 18, 2009
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained virological response
24 weeks after end of treatment
Secondary Outcomes (2)
Virological response over time
At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment
Adverse events; laboratory parameters
Throughout study, laboratory parameters every 2 to 6 weeks
Study Arms (6)
Part 1: Placebo
PLACEBO COMPARATORPlacebo in combination with standard doses of Pegasys and Copegus.
Part 1: RO5190591 300mg po
EXPERIMENTALRO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.
Part 1: RO5190591 600mg po
EXPERIMENTALRO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Part 1: RO5190591 900mg po
EXPERIMENTALRO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Part 2: Placebo
PLACEBO COMPARATORIf the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive placebo in combination with standard doses of Pegasys and Copegus.
Part 2: RO5190591 300mg po
EXPERIMENTALIf the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Interventions
1000 or 1200mg po daily for 24 or 48 weeks
180micrograms sc weekly for 24 or 48 weeks
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- chronic hepatitis C, genotype 1;
- treatment-naive.
You may not qualify if:
- liver cirrhosis and other forms of liver disease;
- HIV infection;
- hepatocellular cancer;
- cardiac disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Unknown Facility
Phoenix, Arizona, 85054, United States
Unknown Facility
Long Beach, California, 90822, United States
Unknown Facility
Los Angeles, California, 90045, United States
Unknown Facility
Sacramento, California, 95817, United States
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San Diego, California, 92123, United States
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San Diego, California, 92154, United States
Unknown Facility
Aurora, Colorado, 80045, United States
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Gainesville, Florida, 32610-0214, United States
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Jacksonville, Florida, 32256, United States
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Orlando, Florida, 32809, United States
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Lombard, Illinois, 60148, United States
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New Orleans, Louisiana, 70112, United States
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Ann Arbor, Michigan, 48109, United States
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Detroit, Michigan, 48202-2689, United States
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Manhasset, New York, 11030, United States
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New York, New York, 10029-6574, United States
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Asheville, North Carolina, 28801, United States
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Chapel Hill, North Carolina, 27599-7584, United States
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Medford, Oregon, 97504, United States
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Lancaster, Pennsylvania, 17604-3200, United States
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San Antonio, Texas, 78215, United States
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Salt Lake City, Utah, 84132, United States
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Vancouver, Washington, 98664, United States
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Milwaukee, Wisconsin, 53210, United States
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Kingswood, New South Wales, Australia
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Adelaide, South Australia, 5000, Australia
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Heidelberg, Victoria, 3084, Australia
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Vienna, 1090, Austria
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Calgary, Alberta, T2N 4Z6, Canada
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Edmonton, Alberta, T5H 4B9, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Vancouver, British Columbia, V5Z 1H2, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Winnipeg, Manitoba, R3A 1R9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 1L7, Canada
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Clichy, 92118, France
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Marseille, 13285, France
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Montpellier, 34295, France
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Paris, 75651, France
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Frankfurt am Main, 60590, Germany
Unknown Facility
Hamburg, 20099, Germany
Unknown Facility
Napoli, Campania, 80131, Italy
Related Publications (1)
Marcellin P, Cooper C, Balart L, Larrey D, Box T, Yoshida E, Lawitz E, Buggisch P, Ferenci P, Weltman M, Labriola-Tompkins E, Le Pogam S, Najera I, Thomas D, Hooper G, Shulman NS, Zhang Y, Navarro MT, Lim CY, Brunda M, Terrault NA, Yetzer ES. Randomized controlled trial of danoprevir plus peginterferon alfa-2a and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection. Gastroenterology. 2013 Oct;145(4):790-800.e3. doi: 10.1053/j.gastro.2013.06.051. Epub 2013 Jun 26.
PMID: 23811112DERIVED
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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 24, 2009
Study Start
August 1, 2009
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11