Hepatitis B, ChronicSTOP-BNCT05328427
Discontinuation of Antiviral Therapy as a Strategy to Cure Hepatitis B
A study testing Stopping in people with Hepatitis B, Chronic, run by Göteborg University at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Stopping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nucleoside analogue treatment for HBeAg-negative chronic hepatitis B for at least 36 months.
Who cannot join
- Liver cirrhosis or liver cancer.
- Co-infection with HCV, HDV or HIV.
- Inability to understand study information and give informed consent
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Infectious Diseases Clinic, Sahlgrenska University Hospital
Gothenburg, VGR, 41650
About this study
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.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Stopping
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StoppingOther
Discontinuation of nucleoside analogue
| Study group | Role | What they receive |
|---|---|---|
| Stopping | Active comparator | Discontinuation of nucleoside analogue treatment Receives: Other: Stopping |
| Continue | No intervention | Treatment with nucleoside analogue continued |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg seronegativisation
Serum HBsAg becoming negative
Measured: 1 year
HBsAg seronegativisation
Serum HBsAg becoming negative
Measured: 2 years
HBsAg reduction
HBsAg reduction by > 1 log IU/mL
Measured: 1 year
HBsAg reduction
HBsAg reduction by > 1 log IU/mL
Measured: 2 years
Clinical responder
Sustained HBV DNA < 2000 IU/mL and normal ALT
Measured: 2 years
Secondary outcomes (1)
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.
Measured: After 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2024
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328427
- Sponsor's protocol ID
- STOP-B
- Acronym
- STOP-B
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2022
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Antiviral Therapy as a Strategy to Cure Hepatitis B
- ClinicalTrials.gov ID
- NCT05328427
- Acronym / sponsor ID
- STOP-B / STOP-B
- Conditions
- Hepatitis B, Chronic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stopping | Active comparator | Other: StoppingDiscontinuation of nucleoside analogue treatment |
| Continue | No intervention | –Treatment with nucleoside analogue continued |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nucleoside analogue treatment for HBeAg-negative chronic hepatitis B for at least 36 months.
Key exclusion criteria (3 listed)
- Liver cirrhosis or liver cancer.
- Co-infection with HCV, HDV or HIV.
- Inability to understand study information and give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StoppingDiscontinuation of nucleoside analogue | Other | Stopping |
Primary outcome
HBsAg seronegativisation
Time frame: 1 year
Serum HBsAg becoming negative
HBsAg seronegativisation
Time frame: 2 years
Serum HBsAg becoming negative
HBsAg reduction
Time frame: 1 year
HBsAg reduction by > 1 log IU/mL
HBsAg reduction
Time frame: 2 years
HBsAg reduction by > 1 log IU/mL
Clinical responder
Time frame: 2 years
Sustained HBV DNA < 2000 IU/mL and normal ALT
1 secondary outcome
HBV-specific T cell activation
Time frame: After 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stopping in people with Hepatitis B, Chronic, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg seronegativisation (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.