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NCT04431245Active, not recruiting

Stopping Antiviral Treatment in Chronic Hepatitis B

Stopping Antiviral Treatment and Subsequent Flare in Chronic Hepatitis B Infection: Immunological and Virological Profiling

Source: ClinicalTrials.gov · Last updated 10 Feb 2026

Brief summary (registry, in English)

Chronic hepatitis B (CHB) infection affected 292 million individuals in the world, translating to about 3.9% of global prevalence. Up to 40% of patients with CHB will develop liver-related complications. Many patients require long-term oral antiviral therapy since off-treatment sustained virological control can only be achieved in a minority of patients. It is uncommon for patients taking long-term antivirals to be able to stop the treatment if favorable factors are not present. Those include low viral load, long enough duration of treatment, and absence of cirrhosis. Some studies have found that inducing a mild flare is beneficial for achieving functional cure in chronic hepatitis B infection. There is lack of data in the immunological and virological profile in patients who stop their long-term antiviral therapy, and in those who developed flare after treatment cessation.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
54 (estimated)
First submitted
31 May 2020
Start date
1 Jun 2021
Primary completion date
31 Aug 2025
Lead sponsor
The University of Hong Kong
Diseases
Hepatitis B
NCT number
NCT04431245

What you commit to

  • Study type: Observational
  • Planned participants: 54
  • From 1 Jun 2021 to the primary completion date, 31 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • HCC, cirrhosis, history of liver transplantation, or on immunosuppressants,

Who the study is looking for

  • HBeAg-negative
  • non-cirrhotic
  • on long-term NA ≥3 years (entecavir or tenofovir)
  • undetectable serum HBV DNA

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Man Fung Yuen
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.