Clinical trial Recruiting at 1 site Phase 4 Interventional

Stopping antiviral treatment for chronic hepatitis B patients

Official title: Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients

Run by Humanity & Health Medical Group Limited · NCT03792919 · Data updated 2026-11-12

This study is testing if people with chronic hepatitis B can safely stop their antiviral medication after being stable for over a year and still maintain good health outcomes.

More Chronic Hepatitis B trials

Quick facts

PhasePhase 4
Study typeInterventional
SexAll
Enrollment2000 (estimated)
SponsorHumanity & Health Medical Group Limited
Academic / other
Locations1 site (Hong Kong, Hong Kong SAR)
StatusRecruiting
StartedDecember 1, 2018
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedMarch 24, 2025
Trial IDNCT03792919 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are HBsAg positive, HBeAg negative CHB patients who have been on stable NAs therapy for at least 18 months and have undetectable HBV DNA.

Probably not a fit

Patients with other liver diseases, concurrent hepatitis viruses, or those unwilling to stop their anti-HBV treatment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to identify chronic hepatitis B (CHB) patients who can safely discontinue nucleos(t)ide analogues (NAs) while maintaining satisfactory clinical outcomes, such as sustained viral remission and HBsAg clearance. It involves comparing the effects of stopping NAs versus continuing treatment in patients who have been stable on NAs for over a year and a half. The study will assess the potential benefits of treatment cessation based on previous findings that suggest increased HBsAg clearance rates after stopping NAs.

Why it matters

Potential benefit: If successful, this study could provide a pathway for CHB patients to safely discontinue antiviral treatment while achieving better health outcomes.

How similar studies have gone: Previous studies have indicated potential success in treatment cessation for similar patient populations, suggesting this approach may be promising.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. HBsAg positive, HBeAg negative, antibody to HBeAg-positive;
2. Stable administration of anti-HBV neucleos(t)ides analogue mono therapy for at least more than one and a half year;
3. Demonstration of undetectable HBV DNA on three occasions, each at least 6 months apart, which is consistent with the APASL stopping rule;
4. Patients read, understand the consent form, and signed the study consent.

Exclusion Criteria:

1. Patient with other liver diseases;
2. Patient with concurrent hepatitis viruses or HIV infection;
3. Patients are reluctant to stop their anti-HBV treatment.

Where it's running

  • Humanity & Health Research Centre
    Hong Kong, Hong Kong SAR, Hong Kong
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.