Efficacy of PEG-IFN alpha-2b and Ribavirin after curative treatment of hepatitis C virus related hepatocellular carcinoma
- Conditions
- Hepatitis C virus related chronic liver disease
- Registration Number
- JPRN-C000000305
- Lead Sponsor
- Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival
- Secondary Outcome Measures
Name Time Method 1) Survival 2) Sustained viral response 3) Sustained biochemical response 4) Safety