Coexistence HBsAg/HBcAC, Clinical Characterístics & Outcomes | NCT05446532

Studies
Coexistence HBsAg/HBcAC, Clinical Characterístics & Outcomes

NCT05446532

Sponsor

Corporacion Parc Tauli

Status

Completed

Last Update Posted

May 31, 2025Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Hepatitis B

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2022Actual

Primary Completion Date

Oct 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jun 29, 2022

First Submission Date that Met QC Criteria

Jul 5, 2022

First Posted Date

Jul 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2025

Last Update Posted Date

May 31, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mireia Miquel-Planas, Principal Investigator, Corporacion Parc TauliPrincipal Investigator

Lead Sponsor

Corporacion Parc TauliOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Label	Type	Description	Intervention Names
Not apply		None. Just registration epidemiology dates

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
H. Consorci Sanitari Parc Tauli		Sabadell	Barcelona		Spain

Condition Browse Module

MeSH Terms

ID	Term
D006509	Hepatitis B

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided