A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.
NCT ID: NCT00517439
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
516 participants
INTERVENTIONAL
2007-12-31
2010-01-31
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
DOUBLE
Study Groups
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Group 1
Group 1 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 po bid) plus PEGASYS (180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Copegus
1000/1200mg po daily for 24 weeks
Pegasys
180 micrograms sc weekly for 24 weeks
RO4588161
1000mg po bid for 24 weeks
Group 2
Group 2 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (500 mg po bid) plus PEGASYS (180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Copegus
1000/1200mg po daily for 24 weeks
Pegasys
180 micrograms sc weekly for 24 weeks
RO4588161
500mg po bid for 24 weeks
Group 3
Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks.
Copegus
1000/1200mg po daily for 24 weeks
Pegasys
180 micrograms sc weekly for 24 weeks
RO4588161
500mg po bid for 24 weeks
Group 4
Group 4 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1500 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Copegus
1000/1200mg po daily for 24 weeks
Pegasys
90 micrograms sc weekly for 24 weeks
RO4588161
1500mg po bid for 24 weeks
Group 5
Group 5 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Copegus
1000/1200mg po daily for 24 weeks
Pegasys
90 micrograms sc weekly for 24 weeks
RO4588161
1000mg po bid for 24 weeks
Group 6
Group 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (500 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Copegus
1000/1200mg po daily for 24 weeks
Pegasys
90 micrograms sc weekly for 24 weeks
RO4588161
500mg po bid for 24 weeks
Group 7
Standard of care (SOC)
Copegus
1000/1200mg po daily for 24 weeks
Pegasys
180 micrograms sc weekly for 24 weeks
Interventions
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Copegus
1000/1200mg po daily for 24 weeks
Pegasys
180 micrograms sc weekly for 24 weeks
Pegasys
90 micrograms sc weekly for 24 weeks
RO4588161
1000mg po bid for 24 weeks
RO4588161
500mg po bid for 24 weeks
RO4588161
1500mg po bid for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* chronic hepatitis C, genotype 1;
* chronic liver disease consistent with CHC;
* compensated liver disease.
Exclusion Criteria
* previous treatment for CHC;
* medical condition associated with chronic liver disease other than CHC;
* HIV, hepatitis A, hepatitis B 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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Phoenix, Arizona, United States
La Jolla, California, United States
Long Beach, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Englewood, Colorado, United States
Bradenton, Florida, United States
Gainesville, Florida, United States
Miami, Florida, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Plymouth, Minnesota, 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
Cincinnati, Ohio, United States
Portland, Oregon, United States
Hershey, Pennsylvania, United States
Providence, Rhode Island, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Sam Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Adelaide, , Australia
Greenslopes, , Australia
Melbourne, , Australia
Sydney, , Australia
Sydney, , Australia
Vienna, , Austria
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Clichy, , France
Créteil, , France
Marseille, , France
Paris, , France
Paris, , France
Pessac, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Cologne, , Germany
Frankfurt am Main, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Hanover, , Germany
Bologna, , Italy
Napoli, , Italy
Torino, , Italy
Santurce, , Puerto Rico
Badalona, , Spain
Barcelona, , Spain
Madrid, , Spain
Seville, , Spain
Valencia, , Spain
Countries
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References
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Nelson DR, Zeuzem S, Andreone P, Ferenci P, Herring R, Jensen DM, Marcellin P, Pockros PJ, Rodriguez-Torres M, Rossaro L, Rustgi VK, Sepe T, Sulkowski M, Thomason IR, Yoshida EM, Chan A, Hill G. Balapiravir plus peginterferon alfa-2a (40KD)/ribavirin in a randomized trial of hepatitis C genotype 1 patients. Ann Hepatol. 2012 Jan-Feb;11(1):15-31.
Other Identifiers
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NV19865
Identifier Type: -
Identifier Source: org_study_id