Efficacy of PEG-IFN alfa-2b plus Ribabirin and HMG-CoA reductase inhibitor combination antiviral therapy ; pilot study

UMIN ID: UMIN000000713

Registered date:09/05/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis C
• Date of first enrollment: 2006/12/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): HMG-CoA reductase inhibitor

Outcome(s)

• Primary Outcome: virologic response

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