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.
Phase 4
- Conditions
- Chronic hepatitis B or cirrhosis with lamivudine-resistance
- Registration Number
- JPRN-UMIN000000602
- 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
- 100
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (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 Measures
Name Time Method (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