Randomized control study to evaluate efficacy and safety of tenofovir alafenamide fumarate for chronically HBV-infected patients treated with entecavir

Randomized control study to evaluate efficacy and safety of tenofovir alafenamide fumarate for chronically HBV-infected patients treated with entecavir - Randomized control study to evaluate efficacy and safety of TAF for chronically HBV-infected patients treated with ETV

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032201

Enrollment

120

Registered

2018-04-11

Start date

2018-04-16

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 virus infection

Interventions

Switch oral administration of entecavir to tenofovir alafenamide fumarate (25 mg/day) and continue for 4 years. Continue entecavir for 4 years.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Chronically HBV-infected patients who have been treated with entecavir for more than 1 year and are positive for HBsAg (2) Serum HBV DNA is less than 3.3 log IU/ml (3) chronic hepatitis or compensated liver cirrhosis (up to Child-Pugh grade A) (4) Age is 20 years old or older (no upper limit, at the registration) (5) Both male and female

Exclusion criteria

Exclusion criteria: (1) Patients who are treated with interferon (2) Patients who are treated with immunosuppressants (3) Patients who have or had hepatocellular carcinoma, or other malignancies (4) Patients who have decompensated liver cirrhosis (5) Patients whose phosphorus is lower than 2.5 mg/dl (6) Patients who are pregnant or have possibilities of pregnancy (7) Patients who are breastfeeding (8) Patients who are infected HIV or HCV (9) Patients who are participating other researches (10) Patients who are considered to be inappropriate for this study

Design outcomes

Primary

Measure	Time frame
Change and negativity rate of HBsAg in every year during 4-year observation	—

Countries

Japan

Contacts

Public ContactMasashi Ninomiya

Tohoku University Hospital Department of Gastroenterology

m-nino5@hello.odn.ne.jp022-717-7171

Outcome results

None listed

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