Efficacy and safety of TAF prophylactic administration for HBV reactivation hepatitis during immunosuppressive or anti-tumor therap

Efficacy and safety of TAF prophylactic administration for HBV reactivation hepatitis during immunosuppressive or anti-tumor therap - TAF for prevention of HBV reactivation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035046

Enrollment

250

Registered

2018-11-28

Start date

2018-07-01

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

Patients with current or previous HBV infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria 1) Patients aged 20 years or older at the time of consent 2) Patients who received an adequate explanation prior to the study and provided written consent for participation in the study 3) (i) Patients who are HBs Ag positive and/or HBV-DNA positive and receive TAF administration for preventing HBV reactivation, ahead of anti-tumor therapy (for solid tumor, malignant lymphoma or leukemia ) or immunosuppressive therapy (for auto immune disease (RA, SLE, nephrosis syndrome, et al),. (ii) Patients who does not meet the criteria described above (i) with previous HBV infection who experience HBV reactivation during anti-tumor therapy or immunosuppressive therapy and receive TAF administration for preventing HBV reactivation hepatitis.

Exclusion criteria

Exclusion criteria: 1) Patients with a past history of hypersensitivity to TAF 2) Patients with serious liver dysfunction (Child-Pugh Class B or C) 3) Patients with difficult-to-control heart disease (e.g., myocardial infarction, heart failure, and arrhythmia) 4) Liver transplantation 5) Patients who are not expected to be survived more than 12 month by the primary physician. 6) Other patients judged to be inappropriate to participate in the study by the primary physician

Design outcomes

Primary

Measure	Time frame
The rate of prevention to HBV reactivation hepatitis at 1 year after initiation of TAF	—

Secondary

Measure	Time frame
1) The rate of prevention to HBV reactivation hepatitis at 2 years after initiation of TAF 2) Disappear of serum HBV-DNA, at 1 years after treatment initiation 3) Safety of TAF administration 4) The change of serum HBs antigen titer during the therapy	—

Countries

Japan

Contacts

Public ContactGoki Suda

Graduate School of Medicine, Hokkaido University Department of Gastroenterology and Hepatology

gsudgast@pop.med.hokudai.ac.jp011-716-2111

Outcome results