A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C
NCT ID: NCT01331850
Last Updated: 2016-11-02
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
381 participants
INTERVENTIONAL
2011-05-31
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Previous null responders (Cohort B): Group 4
Patients 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.
Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
RO5024048
1000 mg oral doses twice a day for 24 weeks
danoprevir
100 mg oral doses twice a day for 24 weeks
ritonavir
100 mg oral doses twice a day for 24 weeks
Previous null responders (Cohort B): Group 5
Patients 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.
Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Pegasys
180 microgram subcutaneously once weekly for 24 weeks
RO5024048
1000 mg oral doses twice a day for 24 weeks
danoprevir
100 mg oral doses twice a day for 24 weeks
ritonavir
100 mg oral doses twice a day for 24 weeks
Previous null responders (Cohort B): Group 6
Patients 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.
Copegus
1000 mg or 1200 mg daily oral doses for 48 weeks
Pegasys
180 microgram subcutaneously once weekly for 48 weeks
RO5024048
1000 mg oral doses twice a day for 24 weeks
danoprevir
100 mg oral doses twice a day for 24 weeks
ritonavir
100 mg oral doses twice a day for 24 weeks
Previous partial responders (Cohort A): Group 1
Patients 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.
Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
RO5024048
1000 mg oral doses twice a day for 24 weeks
danoprevir
100 mg oral doses twice a day for 24 weeks
ritonavir
100 mg oral doses twice a day for 24 weeks
Previous partial responders (Cohort A): Group 2
Patients 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.
Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Pegasys
180 microgram subcutaneously once weekly for 24 weeks
danoprevir
100 mg oral doses twice a day for 24 weeks
ritonavir
100 mg oral doses twice a day for 24 weeks
Previous partial responders (Cohort A): Group 3
Patients 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.
Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Pegasys
180 microgram subcutaneously once weekly for 24 weeks
RO5024048
1000 mg oral doses twice a day for 24 weeks
danoprevir
100 mg oral doses twice a day for 24 weeks
ritonavir
100 mg oral doses twice a day for 24 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Copegus
1000 mg or 1200 mg daily oral doses for 48 weeks
Pegasys
180 microgram subcutaneously once weekly for 24 weeks
Pegasys
180 microgram subcutaneously once weekly for 48 weeks
RO5024048
1000 mg oral doses twice a day for 24 weeks
danoprevir
100 mg oral doses twice a day for 24 weeks
ritonavir
100 mg oral doses twice a day for 24 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
La Jolla, California, United States
Long Beach, California, United States
Sacramento, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Orlando, Florida, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Manhasset, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Medford, Oregon, United States
Providence, Rhode Island, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Darlinghurst, New South Wales, Australia
Kingswood, New South Wales, Australia
Westmead, New South Wales, Australia
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Vienna, , Austria
Porto Alegre, Rio Grande do Sul, Brazil
Ribeirão Preto, São Paulo, Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
La Tronche, , France
Paris, , France
Paris, , France
Pessac, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Essen, , Germany
Kiel, , Germany
Tübingen, , Germany
Napoli, Campania, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Pisa, Tuscany, Italy
Guadalajara, , Mexico
Guadalajara, , Mexico
Bydgoszcz, , Poland
Czeladź, , Poland
Kielce, , Poland
Lodz, , Poland
Warsaw, , Poland
San Juan, , Puerto Rico
Badalona, Barcelona, Spain
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Seville, Sevilla, Spain
Birmingham, , United Kingdom
Dundee, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-019585-90
Identifier Type: -
Identifier Source: secondary_id
WV21913
Identifier Type: -
Identifier Source: org_study_id