Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-01 @ 4:17 AM
Study NCT ID:
NCT06889805
Status:
RECRUITING
Last Update Posted:
2025-03-24
First Post:
2025-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HDV Screening Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003699', 'term': 'Hepatitis D'}], 'ancestors': [{'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-02-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-03-17', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of positive anti-HDV', 'timeFrame': 'at screening', 'description': 'Primary endpoint is seroprevalence rate of positive anti-HDV'}], 'secondaryOutcomes': [{'measure': 'Prevalence rate of detectable HDV RNA', 'timeFrame': 'at screening', 'description': 'Prevalence rate of detectable HDV RNA'}, {'measure': 'Prevalence rate of compensated advanced chronic liver disease', 'timeFrame': 'at screening', 'description': 'Prevalence rate of compensated advanced chronic liver disease (cACLD) defined as a liver stiffness measurement above 10.0 kPa'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HDV'], 'conditions': ['Hepatitis D Virus Infection']}, 'referencesModule': {'references': [{'pmid': '38110005', 'type': 'BACKGROUND', 'citation': 'Lai JC, Wong GL, Wong VW, Yip TC. Unmet need in screening for hepatitis D virus: Time to take action. J Hepatol. 2024 Jun;80(6):e277-e278. doi: 10.1016/j.jhep.2023.12.006. Epub 2023 Dec 16. No abstract available.'}, {'pmid': '37735948', 'type': 'BACKGROUND', 'citation': 'Lui GC, Wong GL, Yang HC, Sheng WH, Lee SH. Current practice and recommendations for management of hepatitis B virus in people living with HIV in Asia. HIV Med. 2023 Oct;24(10):1035-1044. doi: 10.1111/hiv.13545. Epub 2023 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'This is a territory-wide cross-sectional study of all individuals living with HIV/HBV coinfection and HBV-related HCC.', 'detailedDescription': 'Chronic hepatitis B virus (HBV) infection remains endemic in Hong Kong with an estimated prevalence of 6.2% in the recent Population Health Survey 2020-2022.1 The estimated prevalence of chronic HBV infection among individuals living with HIV is 8%.2 Yet, no data are available concerning the disease burden of hepatitis delta virus (HDV) among individuals living with HIV/HBV coinfection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals living with HIV/HBV coinfection and HBV-related HCC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individuals with HIV infection, i.e. anti-HIV or HIV RNA positive; AND\n2. Individuals with chronic hepatitis B, i.e. hepatitis B surface antigen (HBsAg) or HBV DNA positive for two times at least 6 months apart; AND\n3. Aged 18 years old or above.\n4. Written or verbal consent obtained\n\nExclusion Criteria:\n\n1. Refusal to consent\n2. Age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT06889805', 'briefTitle': 'HDV Screening Study', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Universal Screening for Hepatitis Delta Virus (HDV) in Individuals Living with HIV/HBV Coinfection and HBV-related HCC', 'orgStudyIdInfo': {'id': 'SPEARHEAD 2024'}}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Angel Chim', 'role': 'CONTACT', 'email': 'angelchim@cuhk.edu.hk', 'phone': '+85235054205'}], 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Angel Chim', 'role': 'CONTACT', 'email': 'angelchim@cuhk.edu.hk', 'phone': '+85235054205'}], 'overallOfficials': [{'name': 'Lai Hung Grace Wong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grace Lai Hung Wong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Grace Lai Hung Wong', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}