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A randomised comparison of safety and efficacy of triple therapy for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa 2b and ribavirin in HCV patients

Phase 3
Conditions
Chronic hepatitis C
Registration Number
JPRN-UMIN000006952
Lead Sponsor
Hiroshima liver study group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
230
Inclusion Criteria

Not provided

Exclusion Criteria

1)Transient response to prior treatment 2)Patients receiving shosaiko-to 3)Autoimmune hepatitis 4)History of hypersensitivity to PEG-IFN alpha-2b and telaprevir 5)History of hypersensitivity to biological products such as vaccine 6)Decompenstated liver cirrhosis 7)HCC, malignat tumor 8)With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. 9)Pregnant or lactating women and women who may be pregnant 10)Judged by investigator not to be appropriate for inclusion in this study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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