A multicenter randomized controlled trial comparing the efficacy and safety of lamivudine-adefovir combinational therapy with adefovir monotherapy for chronic hepatitis B and cirrhosis with lamivudine-resistance.

A multicenter randomized controlled trial comparing the efficacy and safety of lamivudine-adefovir combinational therapy with adefovir monotherapy for chronic hepatitis B and cirrhosis with lamivudine-resistance. - Adefovir monotherapy for lamivudine-resistant chronic hepatitis B and cirrhosis

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000602

Enrollment

100

Registered

2007-08-01

Start date

2006-12-01

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 with lamivudine-resistance

Interventions

Adefovir-monotherapy arm: Switch from Lamivudine-Adefovir combinational therapy to Adefovir monotherapy, i.e., oral administration of Adefovir dipivoxil (brand name: Hepsera) in a daily dose of 10mg.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Chronic hepatitis B or cirrhosis with positive HBsAg.(2)The patients who are receiving co-administration of adefovir dipivoxil with lamivudine because of lamivudine-resistance (3)HBV DNA level is under 2.6 log copy/ml for more than 3 months before registration.(4)Hepatocellular carcinoma that needs medical treatment is not detected.

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 within 6 months before registration.(3) Pregnant women, or women who are nursing(4) The patients with an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia)(5) The patients with severe chronic renal failure or chronic respiratory failure(6) The patients with other chronic liver disease, such as autoimmune hepatitis, primary biliary cirrhosis, alcoholic hepatitis, or chronic hepatitis C.(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 (2) Rate of the patients whose HBV DNA elevates over 2.6 log copies/ml (3) HBeAg clearance (4) HBeAg seroconversion	—

Secondary

Measure	Time frame
(1) ALT (2)Albumin (3)T.Bil (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(12) YMDD mutation (13) HBV mutation related with Adefovir-resistance	—

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