Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial

Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial - Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021793

Enrollment

Registered

2020-12-31

Start date

2015-07-15

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

Group 1: Continue entecavir Group 2: Switch to tenofovir

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. treated with Entecavir for 5 years or longer 2. HBV-DNA<2.1 log copies/mL 3. HBsAg-positive

Exclusion criteria

Exclusion criteria: 1. no previous use of other nucleoside analog 2. presence of resistance to nucleoside analog 3. other likely causes of chronic liver disease, such as autoimmune or alcoholic liver disease 4. viable HCC or other malignancies 5. decompensated liver function (Child B or C) 6. severe complication (ex. impaired renal, cardiac or respiratory function) 7. women who are possibly pregnant, expectant mothers, and lactating mothers 8. history of allergy to nucleoside analog

Design outcomes

Primary

Measure	Time frame
Decrease in serum HBsAg level on week 240	—

Secondary

Measure	Time frame
Proportion of viral breakthrough until week 240	—

Countries

Japan

Contacts

Public ContactMasaru Enomoto

Osaka Metropolitan University Department of Hepatology

enomoto-m@med.osaka-cu.ac.jp06-6645-3905

Outcome results

None listed

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