A pilot study of switching from multipe nucleos(t)ide analogues to tenofovir alafenamide fumarate monotherapy in patients with chronic hepatits B virus infection

A pilot study of switching from multipe nucleot(s)ide analogues to tenofovir alafenamide fumarate monotherapy in patients with chronic hepatits B virus infection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031220145

Enrollment

Registered

2022-06-18

Start date

2022-06-18

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 hepatits B HBV

Interventions

First, sequencings for reverse transcriptase region of HBV pregenomic HBV-RNA are performed in patients with chronic hepatits B virus infection who are receiving multipe nucleot(s)ide analogues. Seco

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with chronic HBV infection receiving multipe nucleot(s)ide analogues such as ETV plus TAF or LAM plus TAF

Exclusion criteria

Exclusion criteria: Patients who do not consent with clinical trial

Design outcomes

Primary

Measure	Time frame
Viral response rates at 4, 8, 12, 24 and 48 weeks, with the change to TAF monotherapy as week 0	—

Secondary

Measure	Time frame
Changes of WBC, Hb, Plt, Alb, AST, ALT, ALP, LDH, GGT, Cre, BUN, eGFR, T-Chol, TG, Na, Cl, K, T-Bil, PT, M2BPGi, AFP, HBsAg, HBeAg, HBeAb, HBcrAg at 4, 8, 12, 24 and 48 weeks	—

Contacts

Public ContactYoshihito UCHIDA

Saitama Medical University

uchida.yoshihito@1972.saitama-med.ac.jp+81-49-276-1198

Outcome results

None listed

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