Patients with chronic hepatitis C
Conditions
Interventions
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 Ri
Sponsors
Department of Hepatology, Graduate School of Medicine, Osaka City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients with genotype 1b and high titer og HCV
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained viral response rate at 24 weeks after the end of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Nomalization of ALT at 24 weeks after the end of therapy safty of therapy | — |
Countries
Japan
Contacts
Public ContactTadashi Takeda
Graduate School of Medicine, Osaka City University Department of Hepatology
Outcome results
None listed