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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05328427
Other study ID # STOP-B
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2022
Est. completion date December 31, 2025

Study information

Verified date April 2022
Source Göteborg University
Contact Magnus Lindh, MD, PhD
Phone +46705269746
Email magnus.lindh@microbio.gu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date December 31, 2025
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Nucleoside analogue treatment for HBeAg-negative chronic hepatitis B for at least 36 months. Exclusion Criteria: - Liver cirrhosis or liver cancer. - Co-infection with HCV, HDV or HIV. - Inability to understand study information and give informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Stopping
Discontinuation of nucleoside analogue

Locations

Country Name City State
Sweden Infectious Diseases Clinic, Sahlgrenska University Hospital Gothenburg VGR

Sponsors (2)

Lead Sponsor Collaborator
Göteborg University Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary HBsAg seronegativisation Serum HBsAg becoming negative 1 year
Primary HBsAg seronegativisation Serum HBsAg becoming negative 2 years
Primary HBsAg reduction HBsAg reduction by > 1 log IU/mL 1 year
Primary HBsAg reduction HBsAg reduction by > 1 log IU/mL 2 years
Primary Clinical responder Sustained HBV DNA < 2000 IU/mL and normal ALT 2 years
Secondary HBV-specific T cell activation Activation of HBV-specific T-cell responses, induced by incubating whole blood with HBV-core and HBsAg derived peptides for 48 hours, and investigated by measuring gamma interferon, chemokine and cytokine levels in plasma after centrifugation of the stimulated whole blood. After 16 weeks
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