A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection
NCT ID: NCT00192647
Last Updated: 2016-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
896 participants
INTERVENTIONAL
2004-08-31
2009-03-31
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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PEG-IFN alfa-2a+Ribavirin - Induction Treatment
Participants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment.
PEG-IFN alfa-2a
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Ribavirin
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
PEG-IFN alfa-2a+Ribavirin - Standard Treatment
Participants will receive 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses.
PEG-IFN alfa-2a
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Ribavirin
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Interventions
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PEG-IFN alfa-2a
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Ribavirin
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic liver disease consistent with CHC on a biopsy sample obtained within the previous 36 months as judged by a local pathologist (all countries except Australia)
* Infection with Hepatitis C virus (Australian sites only had to meet Section 100 criteria for treatment with PEG-IFN alfa-2a plus ribavirin)
* Compensated liver disease
* Naive to interferon-based therapy for CHC infection
Exclusion Criteria
* Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)
* Chronic liver disease other than CHC infection
18 Years
75 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_CHAIR
Hoffmann-La Roche
Locations
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Buenos Aires, , Argentina
Buenos Aires, , Argentina
La Plata, , Argentina
Rosario, , Argentina
Adelaide, , Australia
Adelaide, , Australia
Bankstown, , Australia
Box Hill, , Australia
Brisbane, , Australia
Cottontree, , Australia
Darlinghurst, , Australia
Douglas, , Australia
Fitzroy, , Australia
Fremantle, , Australia
Geelong, , Australia
Greenslopes, , Australia
Kingswood, , Australia
Lismore, , Australia
Liverpool, , Australia
Liverpool, , Australia
Melbourne, , Australia
Melbourne, , Australia
Melbourne, , Australia
Melbourne, , Australia
Miranda, , Australia
Nedlands, , Australia
New Lambton Heights, , Australia
Parkville, , Australia
Perth, , Australia
Sydney, , Australia
Sydney, , Australia
Sydney, , Australia
Sydney, , Australia
Victoria, , Australia
Woden, , Australia
Wollongong, , Australia
Woolloongabba, , Australia
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Mississauga, Ontario, Canada
Montreal, Quebec, Canada
Guadalajara, , Mexico
Guadalajara, , Mexico
Monterrey, , Mexico
Auckland, , New Zealand
Hamilton, , New Zealand
Riccarton, Christchurch, , New Zealand
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Countries
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Other Identifiers
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ML17908
Identifier Type: -
Identifier Source: org_study_id
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