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

Phase 4

• Conditions: Chronic hepatitis B and cirrhosis

• Registration Number: JPRN-UMIN000000594
• Lead Sponsor: Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Brief Summary

Kobashi H, Miyake Y, Ikeda F, Yasunaka T, Nishino K, Moriya A, Kubota J, Nakamura S, Takaki A, Nouso K, Yamada G, Yamamoto K. Long-term outcome and hepatocellular carcinoma development in chronic hepatitis B or cirrhosis patients after nucleoside analog treatment with entecavir or lamivudine. Hepatology Research 2011 May;41(5):405-16.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-01
• Study Completion: 2010-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(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 Measures

Name	Time	Method
(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