peginterferon alfa-2b and ribavirin plus pitavastatin for chronic hepatitis type C : A pilot study

UMIN ID: UMIN000001605

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: 2009/01/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): peginterferon alfa 2b and ribavirin plus pitavastatin

Outcome(s)

• Primary Outcome: Sustained virologic response
• Secondary Outcome: 1) virologic response at 4,8,12,16,20,24weeks and end of therapyt 2) 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 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