A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection
NCT ID: NCT01220947
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
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COMPLETED
PHASE2
421 participants
INTERVENTIONAL
2010-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Danoprevir
Danoprevir 200 mg BID
Pegasys
Pegasys 180 microgram sc qw
Ritonavir
Ritonavir 100 mg
Group B
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Danoprevir
Danoprevir 100 mg BID
Pegasys
Pegasys 180 microgram sc qw
Ritonavir
Ritonavir 100 mg
Group C
Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Danoprevir
Danoprevir 50 mg BID
Pegasys
Pegasys 180 microgram sc qw
Ritonavir
Ritonavir 100 mg
Group D
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks
Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Danoprevir
Danoprevir 100 mg BID
Pegasys
Pegasys 180 microgram sc qw
Ritonavir
Ritonavir 100 mg
Group E
Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks
Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Pegasys
Pegasys 180 microgram sc qw
Interventions
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Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Danoprevir
Danoprevir 50 mg BID
Danoprevir
Danoprevir 100 mg BID
Danoprevir
Danoprevir 200 mg BID
Pegasys
Pegasys 180 microgram sc qw
Ritonavir
Ritonavir 100 mg
Eligibility Criteria
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Inclusion Criteria
* Chronic Hepatitis C, Genotype 1 and 4
* HCV RNA \>/=50,000 IU/mL
* treatment-naive
Exclusion Criteria
* Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease
18 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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La Jolla, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Orlando, Florida, United States
Orlando, Florida, United States
South Miami, Florida, United States
Decatur, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Lutherville, Maryland, United States
Detroit, Michigan, United States
Manhasset, New York, United States
New York, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Fayetteville, 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
Newport News, Virginia, United States
Vienna, , Austria
Salvador, Estado de Bahia, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Ribeirão Preto, São Paulo, Brazil
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Clichy, , France
Créteil, , France
Marseille, , France
Paris, , France
Rennes, , France
Toulouse, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Frankfurt am Main, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Leipzig, , Germany
Würzburg, , Germany
Bari, Apulia, Italy
Napoli, Campania, Italy
Bologna, Emilia-Romagna, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Novara, Piedmont, Italy
Guadalajara, , Mexico
Monterrey, , Mexico
Santurce, , Puerto Rico
Badalona, Barcelona, Spain
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Seville, Sevilla, Spain
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Nottingham, , United Kingdom
Countries
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Other Identifiers
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2010-019584-10
Identifier Type: -
Identifier Source: secondary_id
NV22776
Identifier Type: -
Identifier Source: org_study_id