Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-03-11 @ 7:35 AM
Study NCT ID:
NCT03362866
Status:
UNKNOWN
Last Update Posted:
2018-09-05
First Post:
2017-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of Hepatitis B, C and Delta in Reunion Island
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D003699', 'term': 'Hepatitis D'}], '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'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2017-11-24', 'studyFirstSubmitQcDate': '2017-11-29', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with hepatitis B, C and Δ in Reunion', 'timeFrame': 'Up to 5 years', 'description': 'Hepatitis diagnosis will be made according to the ongoing guidelines in France (referred by the National AIDS and Hepatitis Research Agency (ANRS)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis B', 'Hepatitis C', 'Hepatitis D']}, 'descriptionModule': {'briefSummary': 'Viral hepatitis B, C and Δ represent a global public health problem for which France was very early mobilized. Despite this, in its foreword, the Dhumeaux report on "Management of people infected with hepatitis B or hepatitis C viruses" identifies a residual area of weakness in this care that is the incomplete regional epidemiological data in the Overseas Territories. The specific ethno-socio-cultural characteristics of these territories make it difficult to transpose data from the mainland France. This study aims at improving our knowledge on the characteristics of patients with hepatitis B, C and Δ in Reunion Island, their follow-up, their evolution and complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hepatitis B, C, D patients in Reunion Island', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMajor patient\n\n* with confirmed HBsAg and / or anti HCV positive Ab\n* residing in Reunion Island\n* followed in one of the participating centers\n\nExclusion Criteria:\n\n• Patient carrying isolated anti HBc antibodies'}, 'identificationModule': {'nctId': 'NCT03362866', 'acronym': 'HEPEPID', 'briefTitle': 'Epidemiology of Hepatitis B, C and Delta in Reunion Island', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Epidemiology of Hepatitis B, C and Delta in Reunion Island', 'orgStudyIdInfo': {'id': '2016/CHU/14'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Olivier Maillard, PharmD', 'role': 'CONTACT', 'email': 'olmaillard@yahoo.fr', 'phone': '+262693025589'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}