A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4
NCT ID: NCT00869661
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
413 participants
INTERVENTIONAL
2001-02-28
2012-02-29
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
DOUBLE
Study Groups
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Group 1
RO5024048 500 mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
Copegus
1000/1200mg po daily for 24 or 48 weeks
Pegasys
180 micrograms sc weekly for 24 or 48 weeks
RO5024048
500mg bid for 12 weeks
Group 2
RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
Copegus
1000/1200mg po daily for 24 or 48 weeks
Pegasys
180 micrograms sc weekly for 24 or 48 weeks
RO5024048
1000mg bid for 8 weeks
Group 3
RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
Copegus
1000/1200mg po daily for 24 or 48 weeks
Pegasys
180 micrograms sc weekly for 24 or 48 weeks
RO5024048
1000mg bid for 12 weeks
Group 4
Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks
Copegus
1000/1200mg po daily for 48 weeks
Pegasys
180 micrograms sc weekly for 48 weeks
RO5024048
1000mg bid for 12 weeks
Group 5
Group 5 will receive SOC for 48 weeks
Copegus
1000/1200mg po daily for 48 weeks
Pegasys
180 micrograms sc weekly for 48 weeks
Group 6
Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks.
Copegus
1000/1200mg po daily for 48 weeks
Pegasys
180 micrograms sc weekly for 48 weeks
RO5024048
1000mg bid for 24 weeks
Interventions
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Copegus
1000/1200mg po daily for 24 or 48 weeks
Copegus
1000/1200mg po daily for 48 weeks
Pegasys
180 micrograms sc weekly for 24 or 48 weeks
Pegasys
180 micrograms sc weekly for 48 weeks
RO5024048
1000mg bid for 24 weeks
RO5024048
500mg bid for 12 weeks
RO5024048
1000mg bid for 8 weeks
RO5024048
1000mg bid for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Chronic hepatitis C, genotype 1 or 4
* Treatment-naive
Exclusion Criteria
* Other forms of liver disease
* HIV infection
18 Years
65 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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Birmingham, Alabama, United States
La Jolla, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Washington D.C., District of Columbia, United States
Bradenton, Florida, United States
Gainesville, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Lutherville, Maryland, United States
Kansas City, Missouri, United States
Newark, New Jersey, United States
New York, New York, United States
Hershey, Pennsylvania, United States
Providence, Rhode Island, United States
Columbia, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Sydney, New South Wales, Australia
Greenslopes, Queensland, Australia
Herston, Queensland, Australia
Woolloongabba, Queensland, Australia
Fitzroy, Victoria, Australia
Melbourne, Victoria, Australia
Nedlands, Western Australia, Australia
Perth, Western Australia, Australia
Vienna, , Austria
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Créteil, , France
La Tronche, , France
Lille, , France
Nice, , France
Paris, , France
Paris, , France
Pessac, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Frankfurt am Main, , Germany
Freiburg im Breisgau, , Germany
Hanover, , Germany
München, , Germany
Ulm, , Germany
Bologna, Emilia-Romagna, Italy
Milan, Lombardy, Italy
Turin, Piedmont, Italy
Pisa, Tuscany, Italy
Santurce, , Puerto Rico
Badalona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Granada, Granada, Spain
A Coruña, La Coruña, Spain
Madrid, Madrid, Spain
Seville, Sevilla, Spain
Valencia, Valencia, Spain
London, , United Kingdom
London, , United Kingdom
Countries
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References
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Tong X, Le Pogam S, Li L, Haines K, Piso K, Baronas V, Yan JM, So SS, Klumpp K, Najera I. In vivo emergence of a novel mutant L159F/L320F in the NS5B polymerase confers low-level resistance to the HCV polymerase inhibitors mericitabine and sofosbuvir. J Infect Dis. 2014 Mar 1;209(5):668-75. doi: 10.1093/infdis/jit562. Epub 2013 Oct 23.
Other Identifiers
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2008-008258-21
Identifier Type: -
Identifier Source: secondary_id
NV20536
Identifier Type: -
Identifier Source: org_study_id