A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C
A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy
2 other identifiers
interventional
381
12 countries
61
Brief Summary
This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2011
CompletedFirst Posted
Study publicly available on registry
April 8, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedNovember 2, 2016
November 1, 2016
1.7 years
March 28, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Sustained virological response (SVR) of danoprevir/ritonavir with RO5024048 and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment
24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir with Pegasys and Copegus in patients with previous partial response to peginterferon/ribavirin treatment
24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment
24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus followed by 24 weeks of Pegasys and Copegus treatment in patients with previous null response to peginterferon/ribavirin treatment
48 weeks
Secondary Outcomes (7)
Safety (Incidence of adverse events) of danoprevir, RO5024048 and Copegus
48 weeks
Safety (Incidence of adverse events) of danoprevir, Pegasys and Copegus
48 weeks
Safety (Incidence of adverse events) of danoprevir, RO5024048, Pegasys and Copegus
72 weeks
Virological response over time
48 weeks
Change in danoprevir plasma concentration
24 weeks
- +2 more secondary outcomes
Study Arms (6)
Previous null responders (Cohort B): Group 4
EXPERIMENTALPatients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Previous null responders (Cohort B): Group 5
EXPERIMENTALPatients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 5 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Previous null responders (Cohort B): Group 6
EXPERIMENTALPatients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.
Previous partial responders (Cohort A): Group 1
EXPERIMENTALPatients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 1 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Previous partial responders (Cohort A): Group 2
EXPERIMENTALPatients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Previous partial responders (Cohort A): Group 3
EXPERIMENTALPatients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 3 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Interventions
1000 mg or 1200 mg daily oral doses for 24 weeks
180 microgram subcutaneously once weekly for 24 weeks
1000 mg oral doses twice a day for 24 weeks
100 mg oral doses twice a day for 24 weeks
100 mg oral doses twice a day for 24 weeks
Eligibility Criteria
You may qualify if:
- Adult patients, age 18 years and older
- Presence of hepatitis C infection, genotype 1a or 1b
- Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks
- Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start
You may not qualify if:
- Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b
- Patients with cirrhosis
- Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response
- Co-infection with hepatitis B or human immunodeficiency virus (HIV)
- History or evidence of chronic liver disease other than hepatitis C
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Unknown Facility
La Jolla, California, 92037-1030, United States
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Long Beach, California, 90822, United States
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Sacramento, California, 95817, United States
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San Diego, California, 92103, United States
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Aurora, Colorado, 80045, United States
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Orlando, Florida, 32804, United States
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Decatur, Georgia, 30033, United States
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Chicago, Illinois, 60637, United States
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New Orleans, Louisiana, 70112, 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, 10021, 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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Providence, Rhode Island, 02905, United States
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Nashville, Tennessee, 37211, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78234, United States
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Darlinghurst, New South Wales, 2010, Australia
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Kingswood, New South Wales, 2747, Australia
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Westmead, New South Wales, 2145, Australia
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Adelaide, South Australia, 5000, Australia
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Melbourne, Victoria, 3004, Australia
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Melbourne, Victoria, 3186, Australia
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Vienna, 1090, Austria
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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
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Ribeirão Preto, São Paulo, 14049-900, Brazil
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Calgary, Alberta, T2N 4Z6, 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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Vancouver, British Columbia, V6Z 2K5, Canada
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London, Ontario, N6A 5A5, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 1L7, Canada
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La Tronche, 38700, France
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Paris, 75651, France
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Paris, 75679, France
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Pessac, 33604, France
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Vandœuvre-lès-Nancy, 54511, France
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Berlin, 13353, Germany
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Essen, 45122, Germany
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Kiel, 24105, Germany
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Tübingen, 72076, Germany
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Napoli, Campania, 80135, Italy
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Milan, Lombardy, 20162, Italy
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Pavia, Lombardy, 27100, Italy
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Pisa, Tuscany, 56124, Italy
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Guadalajara, 44280, Mexico
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Guadalajara, 44650, Mexico
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Bydgoszcz, 85-030, Poland
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Czeladź, 41-250, Poland
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Kielce, 25-317, Poland
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Lodz, 91-347, Poland
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Warsaw, 01-201, Poland
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San Juan, 00927, Puerto Rico
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Badalona, Barcelona, 08915, Spain
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Barcelona, Barcelona, 08003, Spain
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Madrid, Madrid, 28034, Spain
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Madrid, Madrid, 28222, Spain
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Seville, Sevilla, 41014, Spain
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Birmingham, B15 2TH, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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London, E1 1BB, United Kingdom
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London, W2 1PG, United Kingdom
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Manchester, M8 5RB, United Kingdom
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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2011
First Posted
April 8, 2011
Study Start
May 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11