NCT05328427: STOP-B

Discontinuation of Antiviral Therapy as a Strategy to Cure Hepatitis B

Active, enrolled NA Last updated 17 April 2025

What this trial tests

NA trial testing Stopping in Hepatitis B, Chronic in 33 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 November 2022

Primary endpoint
31 December 2024

30 June 2026

Quick facts

Lead sponsor	Göteborg University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	33
Start date	1 November 2022
Primary completion	31 December 2024
Estimated completion	30 June 2026
Sites	1 location across Sweden

Drugs / interventions tested

• Stopping

Conditions studied

• Hepatitis B, Chronic — all drugs for Hepatitis B, Chronic →

Sponsor

Göteborg University

Who can join

18 and older, any sex, with Hepatitis B, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cirrhosis or cancer of the liver caused by hepatitis B virus (HBV) are major global health problems. Chronic HBV infection has become more common in Sweden with immigration. The risk of cancer and the availability of effective antivirals has led to more and more people receiving long-term treatment with antiviral drugs. The disadvantages of this treatment are that it does not have a defined duration and that it very rarely leads to the cure. Several published studies suggest that a large proportion of patients who discontinue antiviral therapy after at least three years may achieve lasting cure of the infection or at least do not need to resume treatment. The mechanism of this effect is not known, but it is thought to be due to the fact that the immune response, which is activated when the amount of virus increases after the end of treatment, becomes more effective in eradicating infected liver cells than it was before starting treatment. As a consequence of these findings updated guidelines for treatment of hepatitis B state that for patients that have received nucleoside analogue treatment for \> 3 years, discontinuation is an accepted therapeutic alternative.

The purpose of the planned study is to investigate the results of discontinued treatment, in terms of clinical outcome as well as immunological and virological mechanisms. The aim is to include 120 patients at four regional infectious diseases clinics (in Gothenburg, Borås, Skövde and Trollhättan), of which 90 will be randomized to discontinue and 30 to continue antiviral treatment. Blood samples will be taken regularly to monitor the outcome and for detailed studies of viral antigens and nucleic acid in the blood and for specific analyzes of the cells of the immune system. The goal is to understand why the discontinued treatment in some patients activates an effective immune response and how such an effect can be predicted even before or early after the treatment is stopped.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.