The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection

The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection - Monitoring by HBs antigen for HBV Reactivation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020029

Enrollment

300

Registered

2015-12-01

Start date

2016-04-01

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

Collagen disease, collagen disease related disease, ulcerative colitis, Crohn&#39

Interventions

Entecavir administration is initiated when serum HBV-DNA levels increased up to 3.0 Log/IU/mL, and/or serum HBs-antigen becomes detectable and serum HBV-DNA levels is 2.0 Log/IU/mL or more.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients tested positive for serum anti-HBs and/or anti-HBc despite of a negative serum HBs-antigen status

Exclusion criteria

Exclusion criteria: Patients tested positive for serum HBs-antigen Patients receiving an HBs-antigen vaccination

Design outcomes

Primary

Measure	Time frame
Both serum HBs-antigen and HBV-DNA are monitored repeatedly every 1 to 3 months during immunosuppressive therapies, and development of de novo HBV hepatitis is evaluated until 12 months after initiation of the therapies.	—

Countries

Japan

Contacts

Public ContactNobuaki Nakayama

Saitama Medical University Department of Gastroenterology and Hepatology

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

Outcome results

None listed

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