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Halting Nucleoside Analogues in Chronic Hepatitis B

NCT04102176 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-14

No results posted yet for this study

Summary

Most patients with Chronic Hepatitis B are on nucleoside analogy (NA) long term, but this leads to HBsAg loss (defined as functional cure) of only 2% at 6 years. Recently a number of studies have shown significant HBsAg loss rates after stopping nucleoside analogues (NA). However, no criteria to select such patients have been evaluated. Consequently, the objective of the study is not only to determine the proportion of patients able to achieve HBsAg loss in those with qHBsAg≤100IU/ml. The study is designed as a randomised control trial with 1:2 parallel arm randomisation to continuing NA or stopping therapy. Patients will be monitored after stopping therapy for Hepatitis B flares and also to document HBsAg loss.

Conditions

Interventions

OTHER

stopping nucleos(t)ide therapy

patients taking nucleoside(t)ide therapy will stop treatment

OTHER

Continue nucleos(t)ide analogue

Continue nucleos(t)ide analogue

Sponsors & Collaborators

  • Tan Tock Seng Hospital

    collaborator OTHER

  • Singapore General Hospital

    collaborator OTHER

  • Changi General Hospital

    collaborator OTHER

  • Seng Gee Lim

    lead OTHER

Principal Investigators

  • Seng Gee Lim, MBBS MD · National University Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04102176 on ClinicalTrials.gov