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.

UMIN ID: UMIN000000597

Registered date:01/08/2007

Basic Information

• Health condition(s) or Problem(s) studied: Chronic hepatitis B and cirrhosis after a curative treatment of hepatocellular carcinoma
• Date of first enrollment: 2006/11/01
• Target sample size: 170
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Entecavir arm: entecavir (brand name: Baraclude) administration orally in a daily dose of 0.5mg before retiring at night, is started within 1 month after registration, and continued for 48 months. Afterwards, the doctor decides to continue or discontinue entecavir administration, dependent on HBV DNA level, ALT level and clinical conditions.
Control arm: The patients receive their therapy without anti viral medications such as entecavir, lamivudine, adefovir dipivoxil or interferon. In the case of development of cancer recurrence or hepatic failure, however, the doctor may start entecavir treatment.

Outcome(s)

• Primary Outcome: (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: (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

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
• Source(s) of Monetary Support: None