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Coexistence HBsAg/HBcAC, Clinical Characterístics & Outcomes

Sponsor
Corporacion Parc Tauli (Other)
Overall Status
Recruiting
CT.gov ID
NCT05446532
Collaborator
Hospital Mutua de Terrassa (Other), Consorci Sanitari de Terrassa (Other), Hospital Universitario La Fe (Other), Germans Trias i Pujol Hospital (Other), Consorci Hospitalari de Vic (Other)
120
Enrollment
1
Location
6.5
Anticipated Duration (Months)
18.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Characteristics of Hepatitis B HBsAg & HBsAc Carriers Simultaneously
    Actual Study Start Date :
    Jun 15, 2022
    Anticipated Primary Completion Date :
    Oct 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Not apply

    None. Just registration epidemiology dates

    Outcome Measures

    Primary Outcome Measures

    1. prevalence concomitant HBsAg and HBsAc markers [10 years]

      To describe the prevalence of concomitant HBsAg and HBsAc markers in our area

    Secondary Outcome Measures

    1. differences between immunocompetent patients with respect to immunocompromised ones. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 H. Consorci Sanitari Parc Tauli Sabadell Barcelona Spain

    Sponsors and Collaborators

    • Corporacion Parc Tauli
    • Hospital Mutua de Terrassa
    • Consorci Sanitari de Terrassa
    • Hospital Universitario La Fe
    • Germans Trias i Pujol Hospital
    • Consorci Hospitalari de Vic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mireia Miquel-Planas, Principal Investigator, Corporacion Parc Tauli
    ClinicalTrials.gov Identifier:
    NCT05446532
    Other Study ID Numbers:
    • 2022/5032
    First Posted:
    Jul 6, 2022
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jul 1, 2022
    Additional relevant MeSH terms:
    Hepatitis B
    Hepatitis

    Study Results

    No Results Posted as of Jul 6, 2022