NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedChronic hepatitis C
Date of first enrollment2009/01/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)peginterferon alfa 2b and ribavirin plus pitavastatin

Outcome(s)

Primary OutcomeSustained virologic response
Secondary Outcome1) 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 minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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

Contact

public contact
Name Yoshiiku Kawakami
Address 1-2-3 kasumi, minami-ku, Hiroshima 734-8551 Japan
Telephone 082-257-5190
E-mail
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
E-mail
Affiliation graduate school of biomedical science, Hiroshima university. Department and medicine and molecular science