Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-04 @ 5:57 PM
Study NCT ID:
NCT05446532
Status:
COMPLETED
Last Update Posted:
2025-05-31
First Post:
2022-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coexistence HBsAg/HBcAC, Clinical Characterístics & Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-07-05', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence concomitant HBsAg and HBsAc markers', 'timeFrame': '10 years', 'description': 'To describe the prevalence of concomitant HBsAg and HBsAc markers in our area'}], 'secondaryOutcomes': [{'measure': 'differences between immunocompetent patients with respect to immunocompromised ones.', 'timeFrame': '10 years', 'description': 'To compare if there are differences in the prevalence or clinical outcome according if the patient has any degree of immunosupresion or not.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all those patients who have been seen in outpatient hepatology consultations and who present positive HBsAg and HBsAc serology simultaneously.\n\nExclusion Criteria:\n\n* Hepatitis C or HIV Co-infection'}, 'identificationModule': {'nctId': 'NCT05446532', 'briefTitle': 'Coexistence HBsAg/HBcAC, Clinical Characterístics & Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Characteristics of Hepatitis B HBsAg & HBsAc Carriers Simultaneously', 'orgStudyIdInfo': {'id': '2022/5032'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Not apply', 'description': 'None. Just registration epidemiology dates'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'H. Consorci Sanitari Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Mutua de Terrassa', 'class': 'OTHER'}, {'name': 'Consorci Sanitari de Terrassa', 'class': 'OTHER'}, {'name': 'Hospital Universitario La Fe', 'class': 'OTHER'}, {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mireia Miquel-Planas', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}