Efficacy of long term combination therapy of PEG-IFN-alpha-2b and Ribavirin for patients with chronic hepatitis C

UMIN ID: C000000235

Registered date:31/12/2009

Basic Information

• Health condition(s) or Problem(s) studied: Patients with chronic hepatitis C
• Date of first enrollment: 2004/12/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

48weeks treatment with PEG-IFN=alpha-2b plus ribavirin.
48weeks treatment with PEG-IFN=alpha-2b plus Ribavirin, and 24weeks treatment with IFN-alpha-2b.
48weeks treatment with PEG-IFN=alpha-2b plus Ribavirin, and 24w treatment with IFN-alpha -2b plus ribavirin.
48weeks treatment with PEG-IFN=alpha-2b plus Ribavirin.
48weeks treatment with PEG-IFN=alpha-2b plus Ribavirin, and 24w treatment with IFN-alpha -2b plus ribavirin.

Outcome(s)

• Primary Outcome: Sustained viral response rate at 24 weeks after the end of therapy
• Secondary Outcome: Nomalization of ALT at 24 weeks after the end of therapy safty of therapy

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Pregnant or lactating women and women who may be pregnant (2) Female patients or male patients with partners who may become pregnant who cannot practice contraception during treatment and 6 months after end of treatment (3) Male patients with pregnant partners who cannot comply with condom use during treatment and 6 months after end of treatment (4) History of hypersensitivity to ribavirin or other nucleoside analogs (5) Inadequately controlled cardiac disease (6) Hemoglobinopathy (7) Chronic renal failure or renal function disorder with creatinine clearance of 50 ml/min or less (8) With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. (9) Serious hepatic function disorder (10) Autoimmune hepatitis (11) History of hypersensitivity to PEG-IFN alfa-2b or other interferons (12) History of hypersensitivity to biological products such as vaccine (13) Patients receiving shosaikoto (14) Judged by investigator to be not appropriate for inclusion in study

Related Information

• Primary Sponsor: Department of Hepatology, Graduate School of Medicine, Osaka City University
• Source(s) of Monetary Support: non