A comparison of peginterferon alfa-2a plus ribavirin and peginterferon alfa-2b plus ribavirin for. postmenopausal women. with chronic hepatitis type C : An open-label randomized controlled trial.

UMIN ID: UMIN000001604

Registered date:26/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis C
• Date of first enrollment: 2008/07/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

PegIFN-alpha2a plus ribavirin
PegIFN-alpha2b plus ribavirin

Outcome(s)

• Primary Outcome: virologic response at 12 weeks
• Secondary Outcome: Sustained virologic response Safety ( moniterd clinical and laboratory evaluation)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1) Patients receiving shosaiko-to 2) Autoimmune hepatitis 3) History of hypersensitivity to PEG-IFN alpha-2a and PEG-IFN alpha-2b 4) History of hypersensitivity to biological products such as vaccine 5) Decompenstated liver cirrhosis 6) HCC, malignat tumor 7) With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. 8) Pregnant or lactating women and women who may be pregnant 9) Judged by investigator not to be appropriate for inclusion in this study

Related Information

• Primary Sponsor: Hiroshima liver study group
• Source(s) of Monetary Support: none