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

UMIN ID: UMIN000001627

Registered date:31/03/2013

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: HBeAg-positive chronic hepatitis B
• Date of first enrollment: 2008/11/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: negative HBeAg, undetectable HBV DNA, and normal ALT at month 12 of entecavir plus HB vaccine combination therapy

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Osaka City University Graduate School of Medicine
• Source(s) of Monetary Support: None