Hepatitis C virus related chronic liver disease
Conditions
Interventions
PEG-IFN alpha-2b 1.0microgram/kg/w+ Ribavirin 400-600mg/day for 48 weeks(Patients with age: under 65 years old, hemoglobin concentration: equal or over 10g/dl, white blood cell count: equal or over 1,
Sponsors
Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Criteria before treatment of hepatocellular carcinoma 1) Patients with first occurrence or first recurrence (after more than 1 year from treatment of hepatocellular carcinoma) of hepatocellular carcinoma 2) Patients without portal venous invasion Criteria after treatment of hepatocellular carcinoma 1) Patients with curative treatment of hepatocellular carcinoma by surgical resection or radiofrequency ablation 2) Patients passed 8 to 12 weeks after treatment of hepatocellular carcinoma and observed no recurrence by imaging test 3) Patients who can treat within 8 weeks after confirming no recurrence by imaging test 4) Hepatitis C virus related chronic liver disease patients with detectable serum HCV RNA
Exclusion criteria
Exclusion criteria: 1) Patients with concomitant carcinoma except for hepatocelular carcinoma 2) Patients with experience of systemic anti-cancer drug treatment for hepatocellular carcinoma 3) Pregnant or lactating women and women who may be pregnant 4) Female patients or male patients with partners who may become pregnant who cannot practice contraception during treatment and 6 months after end of treatment 5) Male patients with pregnant partners who cannot comply with condom use during treatment and 6 months after end of treatment 6) History of hypersensitivity to ribavirin or other nucleoside analogues (acyclovir, ganciclovir, vidarabine etc.) 7) Inadequately controlled cardiac disease (myocardial infarction, cardiac failure, arrhythmia etc.) 8) Hemoglobinopathy (thalassemia, drepanocytic anemia etc.) 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) Autoimmune hepatitis 13) History of hypersensitivity to PEG-IFN alpha-2b or other interferons 14) History of hypersensitivity to biological products such as vaccine 15) Patients receiving shosaiko-to 16) Judged by investigator to be not appropriate for inclusion in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Survival 2) Sustained viral response 3) Sustained biochemical response 4) Safety | — |
Countries
Japan
Contacts
Public ContactToru Kimura
Osaka Red Cross Hospital Department of Gastroenterology and Hepatology
Outcome results
None listed