Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection
NCT ID: NCT00978497
Last Updated: 2017-03-31
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
97 participants
INTERVENTIONAL
2009-09-30
2011-08-31
Brief Summary
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Detailed Description
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Ninety patients will be randomized into 2 cohorts. The forty-five patients in each cohort will be randomized as 30 active: 15 placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Peginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks
placebo
oral BID
Peginterferon
180 μg dose via subcutaneous injection weekly
Ribavirin
oral 1000 mg/day for patients who weighed \< 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg
2
ANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks
ANA598
oral 200mg BID
Peginterferon
180 μg dose via subcutaneous injection weekly
Ribavirin
oral 1000 mg/day for patients who weighed \< 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg
3
ANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks
ANA598
oral 400mg BID
Peginterferon
180 μg dose via subcutaneous injection weekly
Ribavirin
oral 1000 mg/day for patients who weighed \< 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg
Interventions
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placebo
oral BID
ANA598
oral 200mg BID
ANA598
oral 400mg BID
Peginterferon
180 μg dose via subcutaneous injection weekly
Ribavirin
oral 1000 mg/day for patients who weighed \< 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg
Eligibility Criteria
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Inclusion Criteria
* Documented chronic HCV infection, genotype 1a or 1b
* Treatment-naïve
Exclusion Criteria
* Infection with non-genotype 1 HCV
* Previous treatment for HCV infection
* HIV or HBV positive
* Any medical contraindication to Peg-IFN or RBV therapy
* History of any other known cause of liver disease
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Locations
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United States, California 1
Anaheim, California, United States
United States, California 4
Los Angeles, California, United States
United States, California 2
San Clemente, California, United States
United States, California 3
San Diego, California, United States
United States, California 5
San Francisco, California, United States
United States, Florida 2
Gainesville, Florida, United States
United States, Florida 3
Miami, Florida, United States
United States, Florida 1
Sarasota, Florida, United States
United States, Maryland
Lutherville, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
United States, New York
New York, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas 2
Houston, Texas, United States
United States, Texas 1
San Antonio, Texas, United States
United States, Virginia 1
Fairfax, Virginia, United States
United States, Virginia 2
Falls Church, Virginia, United States
Puerto Rico
Santurce, , Puerto Rico
Countries
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Other Identifiers
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ANA598-504
Identifier Type: -
Identifier Source: org_study_id
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