A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
NCT ID: NCT00077649
Last Updated: 2016-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
188 participants
INTERVENTIONAL
2004-01-31
2005-12-31
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
DOUBLE
Study Groups
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PEG-IFN Alfa-2a 180 μg +Ribavirin 1200 mg
Participants received 180 μg of PEG-IFN \[peginterferon\] alfa-2a in 1 mL solution administered \[subcutaneously\] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks
ribavirin [Copegus]
600mg po bid for 48 weeks
peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
180 micrograms sc weekly for 48 weeks
PEG-IFN Alfa-2a 180 μg + Ribavirin 1600 mg
Participants received 180 μg of PEG-IFN \[peginterferon\] alfa-2a in 1 mL solution administered \[subcutaneously\] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks
ribavirin [Copegus]
800mg po bid for 48 weeks
peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
180 micrograms sc weekly for 48 weeks
PEG-IFN Alfa-2a 270 μg + Ribavirin 1200 mg
Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
ribavirin [Copegus]
600mg po bid for 48 weeks
peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
270 micrograms sc weekly for 48 weeks
PEG-IFN Alfa-2a 270 μg + Ribavirin 1600 mg
Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
ribavirin [Copegus]
800mg po bid for 48 weeks
peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
270 micrograms sc weekly for 48 weeks
Interventions
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ribavirin [Copegus]
600mg po bid for 48 weeks
ribavirin [Copegus]
800mg po bid for 48 weeks
peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
180 micrograms sc weekly for 48 weeks
peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
270 micrograms sc weekly for 48 weeks
Eligibility Criteria
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Inclusion Criteria
* body weight \>85kg (187lbs);
* CHC (genotype 1);
* liver biopsy (in \<24 calendar months of first dose), with results consistent with CHC infection;
* use of 2 forms of contraception during study and 6 months after the study in both men and women.
Exclusion Criteria
* male partners of women who are pregnant;
* conditions associated with decompensated liver disease;
* other forms of liver disease, including liver cancer;
* human immunodeficiency virus infection;
* previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
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
Long Beach, California, United States
San Diego, California, United States
San Diego, California, United States
Farmington, Connecticut, United States
Bradenton, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Wellington, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Manhasset, New York, United States
Chapel Hill, North Carolina, United States
Statesville, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Richmond, Virginia, United States
Santurce, , Puerto Rico
Countries
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Other Identifiers
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NV17318
Identifier Type: -
Identifier Source: org_study_id
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