Hepatitis B, ChronicEarly Phase 1SALMONSNCT05550519
A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment
A Early Phase 1 study testing Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) in people with Hepatitis B, Chronic, run by Janssen Pharmaceutica N.V., Belgium.
Trial summary
The purpose of this study is to assess the incidence of participants who reach hepatitis B surface antigen (HBsAg) seroclearance after discontinuing nucleos(t)ide analog (NA) therapy in participants with HBsAg less than or equal to (<=) 100 international units per milliliter (IU/mL) and participants with HBsAg greater… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2022to 28 Aug 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening and during the pre-biopsy assessments. If the results of the serum chemistry panel including liver enzymes, blood coagulation, other specific tests, or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study (in consultation with sponsor)
- Hepatitis B surface antigen (HBsAg) less than or equal to (<=) 500 International units per milliliters (IU/mL) (and greater than [>] 5 IU/mL) at screening
- Hepatitis B e antigen (HBeAg) less than (<) lower limit of quantification and hepatitis B e antibody (HBeAb) positive at screening
- Normal liver ultrasound (at screening or within 3 months before screening [documented evidence])
- Participants must have a body mass index between 18.0 and 35.0 Kilograms per meter square (kg/m^2), extremes included
Who cannot join
- History of or signs of cirrhosis or portal hypertension (absence of nodules, no smooth liver contour, no normal portal vein, spleen size greater than or equal to [>=] 12 centimeters [cm]) or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities on an abdominal ultrasound performed within 3 months prior to screening (based on documented evidence, if available) or at the time of screening. In case of suspicious findings on conventional ultrasound the participant may still be eligible if HCC or clinically relevant renal abnormalities have been ruled out by a more specific imaging procedure (contrast enhanced ultrasound, computed tomography [CT] or magnetic resonance imaging [MRI])
- Participant's refusal to accept blood transfusions
- Participants with clinically relevant drug or alcohol abuse within 12 months before screening
- Received an investigational intervention or used an invasive investigational medical device within 3 months before the planned enrollment or is currently enrolled in an investigational study
- Participants of Asian descent
About this study
Official title: A Prospective Study to Investigate the Relationship Between Hepatitis B Surface Antigen (HBsAg) Loss and the Dynamics in Host and Viral Markers After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment in Chronic Hepatitis B E-antigen Negative Patients With Low On-treatment HBsAg Level
The purpose of this study is to assess the incidence of participants who reach hepatitis B surface antigen (HBsAg) seroclearance after discontinuing nucleos(t)ide analog (NA) therapy in participants with HBsAg less than or equal to (<=) 100 international units per milliliter (IU/mL) and participants with HBsAg greater than (>) 100 IU/mL to <= 500 IU/mL at baseline.
Read the detailed description
Hepatitis B virus (HBV) virus infects the human liver. It consists of a nucleocapsid with hepatitis B core (HBc) protein and a membranous envelope containing hepatitis B surface antigen (HBsAg). Chronic hepatitis B (CHB) virus infection may lead to liver cirrhosis and hepatocellular carcinoma (HCC). Recent guidelines (European Association for the Study of the Liver [EASL] guidelines, Asian Pacific Association for the Study of the Liver [APASL] guidelines) suggest that discontinuation of treatment with nucleos(t)ide analog (NA) (Entecavir [ETV], tenofovir disoproxil fumarate [TDF] or tenofovir alafenamide [TAF]) in non-cirrhotic Hepatitis B e antigen (HBeAg) negative patients after a minimum of three years of viral suppression can trigger changes in virological and immune composition resulting in achieving HBsAg seroclearance (up to 25 percent [%]). The study will be conducted in 3 phases: screening phase (up to 6 weeks), baseline visit (1 day), and post-NA discontinuation phase (up to 96 weeks) which refers to the phase after baseline, in which treatment will be discontinued (off treatment). Discontinuation of NA treatment is considered as study intervention in this study. Collection of core liver biopsy, fine needle aspiration (FNA), and blood samples are considered study investigations/procedures. The participants will be followed for up to 2 years post-NA treatment discontinuation. The total duration of an individual participation will be up to 102 weeks (including up to 6 weeks for screening and baseline).
- Conditions
- Hepatitis B, Chronic
- Being tested
- Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF)
- 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.
Entecavir (ETV)Other
ETV will continue throughout screening and will be stopped at baseline.
Tenofovir Disoproxil Fumarate (TDF)Other
TDF will continue throughout screening and will be stopped at baseline.
Tenofovir Alafenamide (TAF)Other
TAF will continue throughout screening and will be stopped at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Discontinuation of Nucleos(t)ide (NA) Treatment | Experimental | Participants will receive standard of care NA treatment (Entecavir [ETV], Tenofovir Disoproxil Fumarate [TDF], Tenofovir Alafenamide [TAF]) in screening phase (up to 6 weeks) and in baseline visit (Day -1). NA treatment will be discontinued on Day 1 up to 96 weeks (Post-NA discontinuation off-treatment phase). Off-treatment refers to the phase after baseline, in which NA treatment will be discontinued. Receives: Other: Entecavir (ETV); Other: Tenofovir Disoproxil Fumarate (TDF); Other: Tenofovir Alafenamide (TAF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance After Discontinuation of Nucleos(t)ide Analog (NA) Treatment
Percentage of participants with HBsAg seroclearance after discontinuation of NA treatment will be reported.
Measured: At Week 24
Percentage of Participants with HBsAg Seroclearance After Discontinuation of NA Treatment
Percentage of participants with HBsAg seroclearance after discontinuation of NA treatment will be reported.
Measured: At Week 48
Percentage of Participants with HBsAg Seroclearance After Discontinuation of NA Treatment
Percentage of participants with HBsAg seroclearance after discontinuation of NA treatment will be reported.
Measured: At Week 96
Secondary outcomes (9)
Percentage of Participants with Flares
Percentage of participants with flares (virologic, biochemical, and clinical) measured by blood markers (such as HBsAg, hepatitis B virus deoxyribonucleic acid [HBV DNA], and alanine aminotransferase [ALT]) will be reported.
Measured: At Week 24, Week 48, and Week 96
Change from Baseline Over Time in HBsAg Level
Change from baseline over time in HBsAg level will be reported.
Measured: Baseline up to 96 weeks
Change from Baseline Over Time in HBV DNA level
Change from baseline over time in HBV DNA level will be reported.
Measured: Baseline up to 96 weeks
Time to Achieve First HBsAg Seroclearance
Time to achieve first HBsAg seroclearance will be reported.
Measured: Up to 96 weeks
Percentage of Sustained Clinical Responders
Percentage of sustained clinical responders (those with HBsAg seroclearance) will be reported.
Measured: At Week 24, Week 48, and Week 96
Percentage of Participants with HBsAg Seroconversion
Percentage of participants with HBsAg seroconversion will be reported.
Measured: At Week 24, Week 48, and Week 96
Percentage of Participants with Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that results in any of the following conditions that is death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity.
Measured: Up to 96 weeks
Percentage of Participants with Abnormalities in Clinical Laboratory Parameters
Percentage of participants with abnormalities in clinical laboratory parameters will be reported.
Measured: Up to 96 weeks
Percentage of Participants Who Meet the NA Re-Treatment Criteria
Percentage of participants who meet the NA re-treatment criteria will be reported.
Measured: Up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start31 Oct 2022 (estimated)
- Primary completion25 Aug 2025 (estimated)
- Study completion28 Aug 2025 (estimated)
Why it stopped: Sponsor Decision after re-evaluation of strategy in the context of recruitment timelines projection
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.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica N.V., Belgium Clinical Trial, Study director, Janssen Pharmaceutica N.V., Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550519
- Sponsor's protocol ID
- CR109229
- Other IDs
- NOPRODHPB0017, 2021-005588-39
- Acronym
- SALMONS
- Status last verified
- Jun 2025
- First submitted
- 20 Sep 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Investigate the Relationship Between Hepatitis B Surface Antigen (HBsAg) Loss and the Dynamics in Host and Viral Markers After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment in Chronic Hepatitis B E-antigen Negative Patients With Low On-treatment HBsAg Level
- ClinicalTrials.gov ID
- NCT05550519
- Acronym / sponsor ID
- SALMONS / CR109229
- Conditions
- Hepatitis B, Chronic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision after re-evaluation of strategy in the context of recruitment timelines projection
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (estimated)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 28 Aug 2025 (estimated)
- First posted
- 22 Sep 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.
The purpose of this study is to assess the incidence of participants who reach hepatitis B surface antigen (HBsAg) seroclearance after discontinuing nucleos(t)ide analog (NA) therapy in participants with HBsAg less than or equal to (<=) 100 international units per milliliter (IU/mL) and participants with HBsAg greater than (>) 100 IU/mL to <= 500 IU/mL at baseline.
Detailed description
Hepatitis B virus (HBV) virus infects the human liver. It consists of a nucleocapsid with hepatitis B core (HBc) protein and a membranous envelope containing hepatitis B surface antigen (HBsAg). Chronic hepatitis B (CHB) virus infection may lead to liver cirrhosis and hepatocellular carcinoma (HCC). Recent guidelines (European Association for the Study of the Liver [EASL] guidelines, Asian Pacific Association for the Study of the Liver [APASL] guidelines) suggest that discontinuation of treatment with nucleos(t)ide analog (NA) (Entecavir [ETV], tenofovir disoproxil fumarate [TDF] or tenofovir alafenamide [TAF]) in non-cirrhotic Hepatitis B e antigen (HBeAg) negative patients after a minimum of three years of viral suppression can trigger changes in virological and immune composition resulting in achieving HBsAg seroclearance (up to 25 percent [%]). The study will be conducted in 3 phases: screening phase (up to 6 weeks), baseline visit (1 day), and post-NA discontinuation phase (up to 96 weeks) which refers to the phase after baseline, in which treatment will be discontinued (off treatment). Discontinuation of NA treatment is considered as study intervention in this study. Collection of core liver biopsy, fine needle aspiration (FNA), and blood samples are considered study investigations/procedures. The participants will be followed for up to 2 years post-NA treatment discontinuation. The total duration of an individual participation will be up to 102 weeks (including up to 6 weeks for screening and baseline).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Discontinuation of Nucleos(t)ide (NA) Treatment | Experimental | Other: Entecavir (ETV), Other: Tenofovir Disoproxil Fumarate (TDF), Other: Tenofovir Alafenamide (TAF)Participants will receive standard of care NA treatment (Entecavir [ETV], Tenofovir Disoproxil Fumarate [TDF], Tenofovir Alafenamide [TAF]) in screening phase (up to 6 weeks) and in baseline visit (Day -1). NA treatment will be discontinued on Day 1 up to 96 weeks (Post-NA discontinuation off-treatment phase). Off-treatment refers to the phase after baseline, in which NA treatment will be discontinued. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening and during the pre-biopsy assessments. If the results of the serum chemistry panel including liver enzymes, blood coagulation, other specific tests, or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study (in consultation with sponsor)
- Hepatitis B surface antigen (HBsAg) less than or equal to (<=) 500 International units per milliliters (IU/mL) (and greater than [>] 5 IU/mL) at screening
- Hepatitis B e antigen (HBeAg) less than (<) lower limit of quantification and hepatitis B e antibody (HBeAb) positive at screening
- Normal liver ultrasound (at screening or within 3 months before screening [documented evidence])
- Participants must have a body mass index between 18.0 and 35.0 Kilograms per meter square (kg/m^2), extremes included
Key exclusion criteria (5 listed)
- History of or signs of cirrhosis or portal hypertension (absence of nodules, no smooth liver contour, no normal portal vein, spleen size greater than or equal to [>=] 12 centimeters [cm]) or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities on an abdominal ultrasound performed within 3 months prior to screening (based on documented evidence, if available) or at the time of screening. In case of suspicious findings on conventional ultrasound the participant may still be eligible if HCC or clinically relevant renal abnormalities have been ruled out by a more specific imaging procedure (contrast enhanced ultrasound, computed tomography [CT] or magnetic resonance imaging [MRI])
- Participant's refusal to accept blood transfusions
- Participants with clinically relevant drug or alcohol abuse within 12 months before screening
- Received an investigational intervention or used an invasive investigational medical device within 3 months before the planned enrollment or is currently enrolled in an investigational study
- Participants of Asian descent
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 |
|---|---|---|
| Entecavir (ETV)ETV will continue throughout screening and will be stopped at baseline. | Other | Discontinuation of Nucleos(t)ide (NA) Treatment |
| Tenofovir Disoproxil Fumarate (TDF)TDF will continue throughout screening and will be stopped at baseline. | Other | Discontinuation of Nucleos(t)ide (NA) Treatment |
| Tenofovir Alafenamide (TAF)TAF will continue throughout screening and will be stopped at baseline. | Other | Discontinuation of Nucleos(t)ide (NA) Treatment |
Primary outcome
Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance After Discontinuation of Nucleos(t)ide Analog (NA) Treatment
Time frame: At Week 24
Percentage of participants with HBsAg seroclearance after discontinuation of NA treatment will be reported.
Percentage of Participants with HBsAg Seroclearance After Discontinuation of NA Treatment
Time frame: At Week 48
Percentage of participants with HBsAg seroclearance after discontinuation of NA treatment will be reported.
Percentage of Participants with HBsAg Seroclearance After Discontinuation of NA Treatment
Time frame: At Week 96
Percentage of participants with HBsAg seroclearance after discontinuation of NA treatment will be reported.
9 secondary outcomes
Percentage of Participants with Flares
Time frame: At Week 24, Week 48, and Week 96
Change from Baseline Over Time in HBsAg Level
Time frame: Baseline up to 96 weeks
Change from Baseline Over Time in HBV DNA level
Time frame: Baseline up to 96 weeks
Time to Achieve First HBsAg Seroclearance
Time frame: Up to 96 weeks
Percentage of Sustained Clinical Responders
Time frame: At Week 24, Week 48, and Week 96
Percentage of Participants with HBsAg Seroconversion
Time frame: At Week 24, Week 48, and Week 96
Percentage of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 96 weeks
Percentage of Participants with Abnormalities in Clinical Laboratory Parameters
Time frame: Up to 96 weeks
Percentage of Participants Who Meet the NA Re-Treatment Criteria
Time frame: Up to 96 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen Pharmaceutica N.V., Belgium Clinical Trial study director
Janssen Pharmaceutica N.V., Belgium
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) in people with Hepatitis B, Chronic, run by Janssen Pharmaceutica N.V., Belgium.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance After Discontinuation of Nucleos(t)ide Analog (NA) Treatment (time frame: At Week 24). The study lists 3 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 25 Jun 2025; AzTrials last refreshed its copy on 27 Oct 2026.