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The study for usefulness of switching nucleoside/nucleotide analogues (NAs) to tenofovir alafenamide fumarate in patients with chronic HBV infection treated with other NAs

The study for usefulness of switching nucleoside/nucleotide analogues (NAs) to tenofovir alafenamide fumarate in patients with chronic HBV infection treated with other NAs - TAF for chronic HBV infection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030661
Enrollment
200
Registered
2018-01-20
Start date
2018-03-01
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

chronic HBV infection

Interventions

Switch nucleoside/nucleotide analogue to TAF and observe for 5 years

Sponsors

Saitama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with chronic HBV infection who have been treated with entecavir or combination of adefovir and lamivudine for more than 1 year. (2) HBs antigen is more than 80 IU/mL. (3) Over 20 years old.

Exclusion criteria

Exclusion criteria: (1) Patients who is taking immunosuppressive agents (2) Patients who is infected also with HIV (3) Patients treated with contraindicated drug together with TAF. (4) Patients who is considered inappropriate for this study by doctors in attendance

Design outcomes

Primary

MeasureTime frame
HBs antigen level and frequency of occurrence of adverse events (including abnormal clinical laboratory tests) at 5 years after the initiation of TAF administration.

Countries

Japan

Contacts

Public ContactYoshihito UCHIDA

Saitama Medical University Department of Gastroenterology & Hepatology

y_uchida@saitama-med.ac.jp049-276-1198

Outcome results

None listed

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