A randomized trial of lamivudine continuous therapy and entecavir switching therapy for chronic hepatitis B patients treated with lamivudine monotherapy

A randomized trial of lamivudine continuous therapy and entecavir switching therapy for chronic hepatitis B patients treated with lamivudine monotherapy - LVD countinuous therapy vs. ETV switching therapy for CHB patients treated with LVD, randomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001120

Enrollment

100

Registered

2008-04-16

Start date

2008-04-01

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

Interventions

LVD group: Lamivudine 100mg is administered orally once daily. When breakthrough hepatitis is developed by resistant virus to LVD, patients are added 10mg of adefovir dipivoxil once daily on lamivudi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: >Chronic hepatitis B patient with HBsAg positive.(include hepatitis B patients with compensated cirrhosis) >Age; more than 20 years. >LVD has been administered. >In addition, following conditions ((1) or (2)) are required. (1) Administration of LVD; less than 3 years, The levels of HBV DNA; less than 2.6log by Amplicor PCR. (2) Administration of LVD; more than 3 years, The levels of HBV DNA; less than 2.6log by Amplicor PCR.

Exclusion criteria

Exclusion criteria: 1) Concomitant medication of nucleoside analogues except for LVD at present. 2) Concomitant medication of IFN. 3) Concomitant medication of immunosuppressant. 4) HBsAb positive patients. 5) Patients with HCC or other malignancy. 6) Patients with decompensated cirrhosis. 7) Pregnant (or possible) women. 8) Patients with under breast feeding. 9) Co-infection with HIV or HCV 10) Other conditions considered inappropriate by attending physician.

Design outcomes

Primary

Measure	Time frame
To evaluate the following factors after the two-year therapy by LVD or ETV. 1) An incidence of HBV-DNA negative 2) The rate of ALT normalization 3) An incidence of HBeAg seroconversion 4) An incidence of virological breakthrough 5) An incidence of breakthrough hepatitis	—

Secondary

Measure	Time frame
1) Existence of resistant HBV to LVD at the entry 2) An incidence of genotypic resistance a. an incidence of resistant HBV to LVD b. an incidence of resistant HBV to ETV 3) HBV genotype 4) HB core related antigen (HBcrAg)	—

Countries

Japan

Contacts

Public ContactYasuhito Tanaka

Nagoya City University Graduate School of Medical Sciences Clinical Molecular Informative Medicine

ytanaka@med.nagoya-cu.ac.jp052-851-5511

Outcome results

None listed

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