A multicenter open-label randomized controlled trial comparing continuing lamivudine treatment with switching from lamivudine to entecavir treatment for the patients with chronic hepatitis B or cirrhosis receiving lamivudine administration without lamivudine-resistant YMDD mutant virus.
Phase 4
- Conditions
- Chronic hepatitis B or cirrhosis
- Registration Number
- JPRN-UMIN000000601
- 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
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
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 or other nucleoside analogues than lamivudine 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)Change of HBV DNA level and incidence rate of virological breakthrough, i.e., elevation of HBV DNA more than 1 log copy/ml.(2)HBeAg clearance rate(3)HBeAg seroconversion rate(4)Incidence of YMDD mutant virus(5) Incidence of entecavir-resistance related mutation
- Secondary Outcome Measures
Name Time Method (1)ALT (2)s-Albumin (3)Prothrombin time 3(3)T.Bil (5)Platelets count (6) Ascites (7)Hepatic encephalopathy (8)Child-Pugh score (9)Development or recurrence of hepatocellular carcinoma (10)Precore mutant HBV (11)Core promoter mutant HBV