Prospective randomized controlled trial Comparing Peg-IFN alpha-2a monotherapy versus Peg-IFN alpha-2a +ribavirin combination therapy after curative ablation for HCV-positive Hepatocellular Carcinoma
Phase 4
- Conditions
- Chronic hepatitis C Hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000002177
- Lead Sponsor
- Yokohama City University Medical Center Gastroenterological Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 95
Inclusion Criteria
Not provided
Exclusion Criteria
Patient with 1.pregnant or lactating women and women who may be pregnant 2. a man who can not avoid conception during administration of ribavirin and until 6 month after the end ribavirin treatment 3. allergic to ribavirin or nucleoside analogues 4.hemoglobinopathy(thalassemia, sickle cell disease) 5.an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia) 6.an poorly controlled diabetes mellitus and hypertension 7. severe renal disease, Ccr <50ml/min 8. severe depression or psychosomatic disorders 9 .liver disease such as autoimmune hepatitis 10.clinical laboratory date does not meet selection criterion 11. drug allergy against interferon
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival rates 2.5-year survival rates 3.Safety
- Secondary Outcome Measures
Name Time Method 1. Disease-free survival rates (each groups) 2. Changes in the serum HCV RNA level 3. Changes in the serum alanine aminotransferase level