Efficacy of entecavir/IFN alpha sequential therapy for HBeAg-positive chronic active hepatitis B

UMIN ID: UMIN000000808

Registered date:30/09/2011

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: HBeAg-positive chronic active hepatitis B
• Date of first enrollment: 2007/08/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

When HBeAg is negative at month 11 of 0.5mg entecavir therapy, patients will be randomly assigned to receive one of two regimens; in Group A, patients will receive entecavir alone for 7 more months
When HBeAg is negative at month 11 of 0.5mg entecavir therapy, patients will be randomly assigned to receive one of two regimens; in Group B, patients will receive entecavir alone for one more month, then both IFN alpha 5MU (trice weekly) and entecavir for one month, and lastly IFN alpha alone for 5 months.
When HBeAg is positive at month 11 of 0.5mg entecavir therapy (Group C), patients will receive entecavir alone for one more month, then both IFN alpha 5MU (trice weekly) and entecavir for one month, and lastly IFN alpha alone for 5 months.

Outcome(s)

• Primary Outcome: negative HBeAg, undetectable HBV DNA and normal ALT at month 6 after the end of therapy

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. use of lamivudine or any other antiviral agents for hepatitis B within 3 months before the start of therapy 2. presence of lamivudine-resistant YMDD variants 3. clinical signs of decompensated cirrhosis or liver failure 4. other likely causes of chronic liver disease 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