Chronic hepatitis C Hepatocellular carcinoma
Conditions
Interventions
peginterferon alfa-2a monotherapy peginterferon alfa-2a 180microgram(12W) +90microgram(84W):HCV-RNA>
=2log drop
peginterferon alfa-2a in combination with ribavirin:peginterferon alfa-2a 180microgram(12W) +90microgram(84W)+Ribavirin5.5mg/kg 48w(13-60w):HCV-RNA>
=2log drop
peginterferon alfa-2a monotherapy peginterferon alfa-2a 180microgram(12W) +90microgram(84W):HCV-RNA<
=2log drop
Sponsors
Yokohama City University Medical Center Gastroenterological Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with HCV-positive HCC which were curativelty treated with RFA or PEIT 2. Neutrophil>1,500/mm3, Platelet count>70,000/mm3, and Hemoglobin > 10.0/dL 3. Patient who was explained about the study, understood it, and gave the consent form
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival rates 2.5-year survival rates 3.Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease-free survival rates (each groups) 2. Changes in the serum HCV RNA level 3. Changes in the serum alanine aminotransferase level | — |
Countries
Japan
Contacts
Public ContactAkito Nozaki
Yokohama City University Medical Center Gastroenterological Center
Outcome results
None listed