A dose comparing study of peginterferon alfa-2b plus ribavirin in chronic hepatitis type C except genotype 1 and high pretreatment viremia.: A randomized open-label pilot study.

UMIN ID: C000000313

Registered date:27/01/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis C
• Date of first enrollment: 2006/01/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

initial dose of PegIFN 1.5microg/kg
initial dose of PegIFN 1.0microg/kg

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients receiving shosaiko-to 2) Autoimmune hepatitis 3) History of hypersensitivity to PEG-IFN alpha-2b or other interferons 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