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.

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. - Switching from lamivudine to entecavir treatment: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000601

Enrollment

120

Registered

2007-08-01

Start date

2007-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B or cirrhosis

Interventions

Lamivudine continuing group:Lamivudine (brand name: Zefix) administration 100mg per day orally is continued. If HBV DNA elevates above 4 log copy/ml or YMDD mutant HBV is detected by PCR thereafter, t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients with chronic hepatitis B or cirrhosis who have been administered with lamivudine for less than 2 years. (2)Patients with positive HBsAg, normal ALT, and less than 2.6 log copy/ml HBV DNA. (3)YMDD mutant virus was not detected by PCR performed within 40 days before registration.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
(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

Measure	Time frame
(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	—

Countries

Japan

Contacts

Public ContactHaruhiko Kobashi

Okayama university hospital Department of gastroenterology and hepatology

hkobashi@md.okayama-u.ac.jp086-235-7219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026