Efficacy of addition of HB vaccine in patients with chronic hepatitis B who are still HBeAg-positive after one year of entecavir administration: a randomized controlled trial

Efficacy of addition of HB vaccine in patients with chronic hepatitis B who are still HBeAg-positive after one year of entecavir administration: a randomized controlled trial - Entecavir plus HB vaccine combination trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001627

Enrollment

Registered

2013-03-31

Start date

2008-11-01

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

HBeAg-positive chronic hepatitis B

Interventions

Continue oral entecavir administration at a daily dose of 0.5 mg for 12 months Add HB vaccine (to entecavir) by intramuscular injection at a monthly dose of 10 microg for 12 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.persistent or fluctuating elevations of serum ALT for at least 6 months before the start of entecavir 2.positive HBeAg before the start of entecavir 3.detectable HBV DNA before the start of entecavir 4.still HBeAg-positive after one year of entecavir administration

Exclusion criteria

Exclusion criteria: 1.use of lamivudine or any other nucleos(t)ide analogues for hepatitis B 2.use of immunosuppressive or immunomodulatory drugs 3.presence of HCV infection and other likely causes of chronic liver disease 4.clinical signs of decompensated cirrhosis or liver failure 5.severe complication (poor renal, cardiac, or respiratory function) 6.women who are possibly pregnant, expectant mothers, and lactating mothers

Design outcomes

Primary

Measure	Time frame
negative HBeAg, undetectable HBV DNA, and normal ALT at month 12 of entecavir plus HB vaccine combination therapy	—

Countries

Japan

Contacts

Public ContactAkihiro Tamori

Osaka City University Graduate School of Medicine Department of Hepatology

atamori@med.osaka-cu.ac.jp06-6645-3435

Outcome results

None listed

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