Evaluation of the Effect of Nucleos(t)ide Analogue Withdrawal for HBs Antigen Clearance as a Functional Cure for Hepatitis B

Evaluation of the Effect of Nucleos(t)ide Analogue Withdrawal for HBs Antigen Clearance as a Functional Cure for Hepatitis B - Evaluation of the Effect of Nucleos(t)ide Analogue Withdrawal for HBs Antigen Clearance as a Functional Cure for Hepatitis B

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058105

Enrollment

Registered

2025-06-06

Start date

2025-06-06

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 Hepatitis B

Interventions

Discontinuation of Nucleos(t)ide Analog (NA) Therapy for Chronic Hepatitis B

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with HBe antigen-negative hepatitis B receiving NA therapy, in whom serum HBV DNA remains <1.0 Log IU/mL for more than 3 months, and who additionally meet the criteria of HBs antigen <800 IU/mL and HBcr antigen <4.0 Log/mL.

Exclusion criteria

Exclusion criteria: Patients with liver cirrhosis classified as Child-Pugh B or C. Patients with concomitant hepatocellular carcinoma.

Design outcomes

Primary

Measure	Time frame
Proportion of Serum HBs Antigen Clearance Over Four Years After Nucleos(t)ide Analog Discontinuation for Hepatitis B	—

Secondary

Measure	Time frame
Identification of Factors Associated with Response Rate, Efficacy, and Safety	—

Countries

Japan

Contacts

Public ContactTsunamasa Watanabe

St.Marianna University School of Medicine Department of Gastroenterology

twatanab@marianna-u.ac.jp044-977-8111

Outcome results

None listed

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