A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.
NCT ID: NCT00087594
Last Updated: 2016-03-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
48 participants
INTERVENTIONAL
2003-11-30
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Direct Observed Therapy
Participants will receive the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1)
ribavirin
1000/1200mg (\< or \>= 75 kg, respectively), po in two doses daily for 48 weeks (G 1) or 800 mg po in two doses daily for 24 weeks (G 2/3)
Self-Administration Therapy
Participants will receive the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1)
ribavirin
1000/1200mg (\< or \>= 75 kg, respectively), po in two doses daily for 48 weeks (G 1) or 800 mg po in two doses daily for 24 weeks (G 2/3)
Interventions
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peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1)
ribavirin
1000/1200mg (\< or \>= 75 kg, respectively), po in two doses daily for 48 weeks (G 1) or 800 mg po in two doses daily for 24 weeks (G 2/3)
Eligibility Criteria
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Inclusion Criteria
* CHC infection, genotype 1, 2, or 3
* naive to treatment for CHC infection
* enrolled in a methadone maintenance program with documented attendance for at least 3 months
* use of 2 forms of contraception during the study on both men and women
Exclusion Criteria
* co-infection with human immunodeficiency virus (HIV)
* current use of IV or other illicit drugs
* decompensated cirrhosis
* women who are pregnant or breastfeeding
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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San Francisco, California, United States
Farmington, Connecticut, United States
Honolulu, Hawaii, United States
Downers Grove, Illinois, United States
Baltimore, Maryland, United States
New York, New York, United States
Richmond, Virginia, United States
Countries
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Other Identifiers
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ML17251
Identifier Type: -
Identifier Source: org_study_id
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