Coexistence HBsAg/HBcAC, Clinical Characterístics & Outcomes

NCT05446532 | Completed

• 1 other identifier: 2022/5032
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• prevalence concomitant HBsAg and HBsAc markers

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

  10 years

Secondary Outcomes (1)

• differences between immunocompetent patients with respect to immunocompromised ones.

  10 years

Study Arms (1)

Not apply

None. Just registration epidemiology dates

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Hepatitis C or HIV Co-infection

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Hospital Mutua de Terrassa: collaborator
• Consorci Sanitari de Terrassa: collaborator
• Hospital Universitario La Fe: collaborator
• Germans Trias i Pujol Hospital: collaborator

Study Sites (1)

H. Consorci Sanitari Parc Tauli

Sabadell, Barcelona, Spain

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 6, 2022
• Study Start: June 15, 2022
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

ES (1)