Hepatitis B surface antigen, core-related antigen and HBV RNA: Predicting clinical relapse after NA therapy discontinuation

The Role of Quantitative Hepatitis B surface antigen, Hepatitis B core related antigen and Hepatitis B RNA in Prediction of Hepatitis B Relapse after Nucleos(t)ides Analogues Discontinuation in Chronic Hepatitis B.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

TCTR

Registry ID

TCTR20180316007

Enrollment

Registered

2018-03-16

Start date

2018-02-05

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

To evaluate the HBV off-therapy relapse rate after discontinuation of NA. To determine the correlation of the new seromarkers to predict the HBV off-therapy relapse of non-cirrhotic chronic hepatiti chronic hepatitis B, CHB, antiviral discontinuation, relapse, qHBsAg, HBcrAg, HBV RNA

Interventions

Non-cirrhotic chronic hepatitis B infection: non-cirrhosis defined from either standard imaging or histology diagnosis of non-cirrhosis and the liver stiffness measure by transient elastography less t

Other

Non cirrhotic chronic hepatitis B infection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients 18 years of age and older - Receiving treatment with nucleos(t)ide analogue - Meet the standard stopping criteria of of the 2015 update of APASL clinical practice guideline

Exclusion criteria

Exclusion criteria: The sample did not include patients with advanced fibrosis or cirrhosis, defined as liver stiffness measured by transient elastography as 11 kPa or more or as Meta-analysis of Histological Data in Viral Hepatitis (METAVIR) stage 3 or higher on liver biopsy, or in whom imaging showed evidence of cirrhosis within the previous 6 months and at baseline before NA initiation. The sample also did not include patients with active hepatocellular carcinoma or other malignancies, those with co-infection with hepatitis C virus or human immunodeficiency virus, those undergoing concomitant treatment with immunosuppressive agents, those with other chronic liver disease, pregnancy or lactating women and patients who refused to participate in the study.

Design outcomes

Primary

Measure	Time frame
The HBV off-therapy relapse rate within 1 year after discontinuation NA according to the APASL2015 1 year after discontinuation of NA. Viral relapse is defined as serum HBV DNA greater than 2000 IU/ml after stopping treatment	—

Secondary

Measure	Time frame
The correlation of seromarkers 1 year after discontinuation of NA qHBsAg, HBcrAg, HBV RNA	—

Countries

Thailand

Contacts

Public ContactApichat Kaewdech

Faculty of Medicine, Prince of Songkla University

apichatka@hotmail.com0828013379

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026