Hepatitis BNCT05446532
Coexistence HBsAg/HBcAC, Clinical Characterístics & Outcomes
An observational study of Hepatitis B, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
HBV infection is a dynamic process with complex interactions between virus replication and the host's immune response. The appearance of anti-HBs after HBV infection generally indicates recovery and immunity to HBV1 infection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatitis B
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2022to 31 Dec 2022
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All those patients included all patients visited asoutpatient hepatology consultations of the respective centers in the last 10 years (between 01/01/2010 and 12/31/2020) and who present positive HBsAg and HBsAc serology simultaneously.
Who may be able to join
- all those patients who have been seen in outpatient hepatology consultations and who present positive HBsAg and HBsAc serology simultaneously.
Who cannot join
- Hepatitis C or HIV Co-infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of Hepatitis B HBsAg & HBsAc Carriers Simultaneously
HBV infection is a dynamic process with complex interactions between virus replication and the host's immune response. The appearance of anti-HBs after HBV infection generally indicates recovery and immunity to HBV1 infection. However, there are several published studies that describe the coexistence of the marker of chronic infection (HBsAg +) and the marker of functional cure (HBsAc +). There are contradictory studies on whether the coexistence of HBsAg/HBsAc implies a different clinical course.
- Conditions
- Hepatitis B
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Not apply | None. Just registration epidemiology dates |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence concomitant HBsAg and HBsAc markers
To describe the prevalence of concomitant HBsAg and HBsAc markers in our area
Measured: 10 years
Secondary outcomes (1)
differences between immunocompetent patients with respect to immunocompromised ones.
To compare if there are differences in the prevalence or clinical outcome according if the patient has any degree of immunosupresion or not.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start15 Jun 2022
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Consorci Sanitari de Terrassa, Hospital Universitario La Fe, Germans Trias i Pujol Hospital
- Responsible party
- Principal investigator, Mireia Miquel-Planas, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446532
- Sponsor's protocol ID
- 2022/5032
- Status last verified
- May 2025
- First submitted
- 29 Jun 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Hepatitis B HBsAg & HBsAc Carriers Simultaneously
- ClinicalTrials.gov ID
- NCT05446532
- Acronym / sponsor ID
- 2022/5032
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Consorci Sanitari de Terrassa, Hospital Universitario La Fe, Germans Trias i Pujol Hospital
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Jul 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.
HBV infection is a dynamic process with complex interactions between virus replication and the host's immune response. The appearance of anti-HBs after HBV infection generally indicates recovery and immunity to HBV1 infection. However, there are several published studies that describe the coexistence of the marker of chronic infection (HBsAg +) and the marker of functional cure (HBsAc +). There are contradictory studies on whether the coexistence of HBsAg/HBsAc implies a different clinical course.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Not apply | – | –None. Just registration epidemiology dates |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All those patients included all patients visited asoutpatient hepatology consultations of the respective centers in the last 10 years (between 01/01/2010 and 12/31/2020) and who present positive HBsAg and HBsAc serology simultaneously.
Key inclusion criteria (1 listed)
- all those patients who have been seen in outpatient hepatology consultations and who present positive HBsAg and HBsAc serology simultaneously.
Key exclusion criteria (1 listed)
- Hepatitis C or HIV Co-infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence concomitant HBsAg and HBsAc markers
Time frame: 10 years
To describe the prevalence of concomitant HBsAg and HBsAc markers in our area
1 secondary outcome
differences between immunocompetent patients with respect to immunocompromised ones.
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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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?
An observational study of Hepatitis B, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 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: finished, as of the sponsor's last update on 31 May 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
prevalence concomitant HBsAg and HBsAc markers (time frame: 10 years). 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 31 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.