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JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001735

Registered date:01/06/2009

Effectiveness of PEG-IFN alfa-2b + Ribavirin combination therapy in patients with chronic hepatitis C after partial splenic embolization(PSE) or splenectomy

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedChronic Hepatitis C
Date of first enrollment2009/03/01
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)All patients are treated with PEG-IFN alfa-2b 1.0-1.5 microgram/kg/week + Ribavirin 400-1000/day. Treatment duration is 48-72 weeks for HCV genotype1 with high viral load and up to 24 weeks for HCV genotype1 with low viral load or genotype2.

Outcome(s)

Primary OutcomeSustained virological response(SVR)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria1)Platelet count <80,000/mm3 before PSE or splenectomy 2)Platelet count 80,000/mm3 or more before initiation of PEG-IFN alfa-2b + Ribavirin treatment 3)High serum HCV levels of 5 log IU/ml or more(TaqMan) or previous IFN treatment failure
Exclude criteria1)History of hypersensitivity to PEG-IFN alpha-2b or other interferons 2)History of hypersensitivity to biological products such as vaccine 3)Patients receiving shosaiko-to 4)Autoimmune hepatitis 5)Pregnant or lactating women and women who may be pregnant 6)History of hypersensitivity to ribavirin or other nucleoside analogs 7)Inadequately controlled cardiac disease 8)Hemoglobinopathy 9)Chronic renal failure or renal function disorder with creatinine clearance of 50 ml/min or less 10)With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. 11)Serious hepatic function disorder 12)Judged by investigator not to be appropriate for inclusion in this study

Related Information

Contact

public contact
Name
Address 2-34, kitajyosanjima-cho, tokushima-shi, tokushima, Japan Japan
Telephone
E-mail
Affiliation Tokushima Municipal Hospital Department of Internal Medicine
scientific contact
Name Akemi Tsutsui
Address 2-34, kitajyosanjima-cho, tokushima-shi, tokushima, Japan Japan
Telephone
E-mail
Affiliation Tokushima Municipal Hospital Department of Internal Medicine