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

Efficacy of entecavir/IFN alpha sequential therapy for HBeAg-positive chronic active hepatitis B - Entecavir/IFN sequential therapy for chronic hepatitis B (B-SHOT study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000808

Enrollment

Registered

2011-09-30

Start date

2007-08-01

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 active hepatitis B

Interventions

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 positi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. persistent or fluctuating elevations of serum ALT for at least 6 months 2. positive HBeAg 3. detectable HBV DNA

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
negative HBeAg, undetectable HBV DNA and normal ALT at month 6 after the end of therapy	—

Countries

Japan

Outcome results

None listed

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