UMIN ID: UMIN000001605
Registered date:26/12/2008
peginterferon alfa-2b and ribavirin plus pitavastatin for chronic hepatitis type C : A pilot study
Basic Information
Recruitment status | Complete: follow-up complete |
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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 |
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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 |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | none |
Secondary ID(s) |
Contact
public contact | |
Name | Yoshiiku Kawakami |
Address | 1-2-3 kasumi, minami-ku, Hiroshima 734-8551 Japan |
Telephone | 082-257-5190 |
Affiliation | graduate school of biomedical science, Hiroshima university Department and medicine and molecular science |
scientific contact | |
Name | Kazuaki Chayama |
Address | 1-2-3 kasumi, minami-ku, Hiroshima 734-8551 Japan |
Telephone | 082-257-5190 |
Affiliation | graduate school of biomedical science, Hiroshima university. Department and medicine and molecular science |