Efficacy and safty of tenofovir alafenamide treatment swithed from entecavir in patinets with chronic hepatitis B.

Efficacy and safty of tenofovir alafenamide treatment swithed from entecavir in patinets with chronic hepatitis B. - Efficacy and safty of tenofovir alafenamide swithed from entecavir.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031754

Enrollment

100

Registered

2018-07-01

Start date

2018-04-20

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

Tenofovir alafenamide switched from entecavir in patinets with low HBV DNA level. treatment period

3 years Tenofovir alafenamide 25mg/day interventin time: one control group

entecavir continued. entecavir 0.5mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: entecavir treatment period; more than 1 year more than 20 years old HBsAg positive HBV DNA; less than 3.0 log IU/mL (more than 1 year)

Exclusion criteria

Exclusion criteria: Ccr less than 15 mL/min patients who can't have informed consent. Doctors jugde inadequate patients.

Design outcomes

Primary

Measure	Time frame
The mean and median decline in HBsAg level of tenofovir alafenamide at 1, 2 , 3 years after randomization.	—

Secondary

Measure	Time frame
HBsAg and HBeAg seloclearance rates at 1, 2 , 3 years after randomization. Rates of HBsAg < 100 IU/mL amd < 1000 IU/mL and HBV DNA elevation rates. Ccr, eGFR, Urine and serum phosphorus	—

Countries

Japan

Contacts

Public ContactFumitaka Suzuki

Department of Hepatology Department of Hepatology

fumitakas@toranomon.gr.jp0448775111

Outcome results

None listed

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