Coexistence HBsAg/HBcAC, Clinical Characterístics & Outcomes

May 27, 2025 updated by: Mireia Miquel-Planas, Corporacion Parc Tauli

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain
        • H. Consorci Sanitari Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • all those patients who have been seen in outpatient hepatology consultations and who present positive HBsAg and HBsAc serology simultaneously.

Exclusion Criteria:

  • Hepatitis C or HIV Co-infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Not apply
None. Just registration epidemiology dates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence concomitant HBsAg and HBsAc markers
Time Frame: 10 years
To describe the prevalence of concomitant HBsAg and HBsAc markers in our area
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
differences between immunocompetent patients with respect to immunocompromised ones.
Time Frame: 10 years
To compare if there are differences in the prevalence or clinical outcome according if the patient has any degree of immunosupresion or not.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Collaborators

Germans Trias i Pujol Hospital
Hospital Universitario La Fe
Hospital Mutua de Terrassa
Consorci Sanitari de Terrassa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/5032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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