A multicenter, randomized controlled trial of entecavir treatment for the patients with hepatocellular carcinoma complicated with chronic hepatitis B or cirrhosis after a curative treatment of the cancer: Anti-virus effect, influence on hepatic reserve, cancer recurrence, and survival.
Phase 4
- Conditions
- Chronic hepatitis B and cirrhosis after a curative treatment of hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000000597
- Lead Sponsor
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 170
Inclusion Criteria
Not provided
Exclusion Criteria
(1)The patients who has an allergy against nucleos(t)ide analogues(2)The patients who have received interferon or nucleoside analogue within 6 months before registration(3) Pregnant women, or women who are nursing.(4)The patients with other chronic liver disease, such as autoimmune hepatitis, primary biliary cirrhosis, alcoholic hepatitis, or chronic hepatitis C.(5)The patients with an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia)(6)The patients with chronic renal failure or chronic respiratory failure(7)The patients who were thought to be inapproriate for this study by the doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1)Recurrence-free survival: recurrence or not is diagnosed by enhanced CT, enhanced MRI, or ultrasonography.(2)AFP, AFP-L3, PIVKA-II (3)Survival (4)Event-free survival, i.e., survival without gastrointestinal hemorrhage or development(or aggravation) of hepatic failure such as jaundice, ascites, or hepatic encephalopathy.
- Secondary Outcome Measures
Name Time Method (1)Change of HBV DNA from pretreatment level, rate of the patients whose HBV DNA level decrease below 2.6 log copy/ml. (2)Clearance or seroconversion of HBeAg (3)ALT, albumin, prothrombin time (%), total bilirubin, platelet count, ascites (none, slight, moderate or much) (4)Emergence of entecavir-resistance