Coexistence HBsAg/HBcAC, Clinical Characterístics & Outcomes

Hepatitis B Clinical Trial

Official title:

Characteristics of Hepatitis B HBsAg & HBsAc Carriers Simultaneously

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05446532
• Other study ID #: 2022/5032
• Status: Recruiting
• Start date: June 15, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Locations

Country	Name	City	State
Spain	H. Consorci Sanitari Parc Tauli	Sabadell	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Consorci Hospitalari de Vic, Consorci Sanitari de Terrassa, Germans Trias i Pujol Hospital, Hospital Mutua de Terrassa, Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence concomitant HBsAg and HBsAc markers	To describe the prevalence of concomitant HBsAg and HBsAc markers in our area	10 years
Secondary	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.	10 years