A multicenter randomized controlled trial comparing the efficacy and safety of lamivudine-adefovir combinational therapy with adefovir monotherapy for chronic hepatitis B and cirrhosis with lamivudine-resistance.

UMIN ID: UMIN000000602

Registered date:01/08/2007

Basic Information

• Health condition(s) or Problem(s) studied: Chronic hepatitis B or cirrhosis with lamivudine-resistance
• Date of first enrollment: 2006/12/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Adefovir-monotherapy arm: Switch from Lamivudine-Adefovir combinational therapy to Adefovir monotherapy, i.e., oral administration of Adefovir dipivoxil (brand name: Hepsera) in a daily dose of 10mg. If HBV DNA re-elevates or ALT re-elevates above two-fold of baseline afterwards, Lamivudine (brand name: Zefix) administration in a daily dose of 100 mg is re-started.
Lamivudine-adefovir combinational therapy arm: Combinational therapy of Lamivudine (brand name: Zefix) 100 mg per day and Adefovir dipivoxil (brand name: Hepsera) 10mg per day is continued.

Outcome(s)

• Primary Outcome: (1) Change of HBV DNA (2) Rate of the patients whose HBV DNA elevates over 2.6 log copies/ml (3) HBeAg clearance (4) HBeAg seroconversion
• Secondary Outcome: (1) ALT (2)Albumin (3)T.Bil (4)Prothrombin time (%) (5) Platelet count(6)Ascites (7)Hepatic encephalopathy (8)Develpoment of hepatocellular carcinoma(9) HBV precore mutation (10) HBV core promoter mutation (11) Child-Pugh score(12) YMDD mutation (13) HBV mutation related with Adefovir-resistance

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: (1) The patients who has a history of an allergy against nucleos(t)ide analogues(2) The patients who have received interferon within 6 months before registration.(3) Pregnant women, or women who are nursing(4) The patients with an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia)(5) The patients with severe chronic renal failure or chronic respiratory failure(6) The patients with other chronic liver disease, such as autoimmune hepatitis, primary biliary cirrhosis, alcoholic hepatitis, or chronic hepatitis C.(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