A multicenter open-label trial of entecavir treatment for chronic hepatitis B and cirrhosis: Effectiveness and safety

UMIN ID: UMIN000000594

Registered date:01/08/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis B and cirrhosis
• Date of first enrollment: 2010/12/01
• Target sample size: 65
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Entecavir (brand name: Baraclude) is administered orally in a daily dose of 0.5 mg before retiring at night.

Outcome(s)

• Primary Outcome: (1)Change of HBV DNA (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: (1)ALT (2)Albumin (3)T.Bilirubin (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

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: (1) The patient who has an allergy against nucleios(t)ide analogues. (2) Pregnant women, or the women who are nursing.(3) The patients with an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia).(4) The patients with serious chronic renal failure, or chronic respiratory failure.(5) The patient who was thought to be inappropriate for the 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