A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4
NCT ID: NCT01057667
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
168 participants
INTERVENTIONAL
2010-02-28
2012-04-30
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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Arm A: With RO5024048
Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily).
RO5024048
1000mg bid po, 24 weeks
Ribavirin [Copegus]
1000mg or 1200mg po daily
peginterferon alfa-2a [Pegasys]
180mcg sc weekly
Arm B: Standard treatment
Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks.
Ribavirin [Copegus]
1000mg or 1200mg po daily
peginterferon alfa-2a [Pegasys]
180mcg sc weekly
Interventions
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RO5024048
1000mg bid po, 24 weeks
Ribavirin [Copegus]
1000mg or 1200mg po daily
peginterferon alfa-2a [Pegasys]
180mcg sc weekly
Eligibility Criteria
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Inclusion Criteria
* hepatitis C, genotype 1 or 4, of over 6 months duration
* treatment-naïve
* negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin
Exclusion Criteria
* previous interferon or ribavirin based therapy or investigational anti-HCV agent
* systemic antiviral therapy with established or perceived activity against HCV \</=3 months prior to first dose of study drug
* hepatitis A or B, or HIV infection
* history or evidence of medical condition associated with chronic liver disease other than HCV
18 Years
70 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
Bradenton, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Kansas City, Missouri, United States
Lebanon, New Hampshire, United States
Albuquerque, New Mexico, United States
New York, New York, United States
New York, New York, United States
The Bronx, New York, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
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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NV22621
Identifier Type: -
Identifier Source: org_study_id