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

UMIN ID: UMIN000001735

Registered date:01/06/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Hepatitis C
• Date of first enrollment: 2009/03/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• 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 Outcome: Sustained virological response(SVR)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)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

• Primary Sponsor: Tokushima Municipal Hospital
• Secondary Sponsor: Musashino Red Cross Hospital
• Source(s) of Monetary Support: None