Prediction and Assessment of Hepatitis B Virus Reactivation Risk Under Immunosuppressive Therapy

Prediction and Assessment of Hepatitis B Virus Reactivation Risk Under Immunosuppressive Therapy - HBV Reactivation Risk Prediction Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000062030

Enrollment

300

Registered

2026-06-23

Start date

2026-06-23

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBV reactivation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with resolved HBV infection, defined as HBsAg-negative and anti-HBc and/or anti-HBs-positive, who showed seroconversion of serum HBV DNA from below the detection or quantification limit and were diagnosed with HBV reactivation.

Exclusion criteria

Exclusion criteria: Cases of HBV infection/reactivation considered to be derived from the graft liver after living donor liver transplantation will be excluded.

Design outcomes

Primary

Measure	Time frame
Progression to clinically significant HBV reactivation (HBV DNA >3.3 log IU/mL)	—

Secondary

Measure	Time frame
the rate of spontaneous viral clearance, longitudinal changes in HBV DNA levels, the incidence of hepatitis accompanied by ALT elevation, the initiation and timing of nucleos(t)ide analogue therapy, and the discriminatory performance and diagnostic accuracy of the developed prediction model	—

Countries

Japan

Contacts

Public ContactTadashi Inuzuka

Kyoto University, Graduate School of Medicine Gastroenterology and Hepatology Department

tinuzuka@kuhp.kyoto-u.ac.jp0757514319

Outcome results