A multicenter open-label randomized controlled trial comparing interferon-entecavir sequential therapy with interferon monotherapy for chronic hepatitis B
- Conditions
- chronic hepatitis B
- Registration Number
- JPRN-UMIN000000595
- 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
Not provided
(1)The patients who have an allergy against interferons (2)The patients who have an allergy against nucleos(t)ide analogues (3)The patients who have received interferon or nucleoside analogue within 6 months before registration (4)Pregnant women, or women who are nursing (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 with a severe mental disease such as depression, a suicide consideration, or a suicide project, or the past history of such conditions (8)The patients with liver cirrhosis or severe hepatic diseases (9)The patients having a past history of cerebral hemorrhage or cerebral infarction (10)The patients with other liver diseases such as autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver injury, or chronic hepatitis C (11)The patients having non-liver autoimmune diseases, such as rheumatoid arthritis (12)The patients who are prescribed with Shoh-saiko-toh (13)The patients who were judged inappropriate for the 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 from baseline (2)Fall of HBV DNA to less than 2.6 log copies/ml (3)HBeAg clearance (4)HBeAg seroconversion (5)Emergence of entecavir-resistance
- Secondary Outcome Measures
Name Time Method (1)ALT (2)Albumin (3)Prothrombin time(%) (4)Total Bilirubin (5)Platelet count (6)Ascites (7)Hepatic encephalopathy (8)Child-Pugh score (9)Development of hepatocellular carcinoma (10)HBV precore mutation (11)HBV core promoter mutation