Chronic hepatitis B and cirrhosis
Conditions
Interventions
Entecavir (brand name: Baraclude) is administered orally in a daily dose of 0.5 mg before retiring at night.
Sponsors
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Chronic hepatitis B or cirrhosis with positive HBsAg, abnormal ALT, and serum HBV DNA over 5 Log copies/ml
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (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
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactHaruhiko Kobashi
Okayama university hospital Department of gastroenterology and hepatology
Outcome results
None listed