Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-30 @ 2:02 AM
Study NCT ID:
NCT05264259
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2022-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2022-02-21', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability of the isolated monoclonal antibodies to neutralize all 3 BKV genotypes', 'timeFrame': '5 years', 'description': 'The neutralization titer will be defined as the dilution of the sample that produced 50% inhibition of pseudovirion infectivity (IC50)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['BK Virus Infection']}, 'descriptionModule': {'briefSummary': 'BK virus (BKV) infection has a major negative impact on transplant recipients. No BKV-specific antiviral therapy is available, so there is an urgent need to develop new anti-BKV preventive and therapeutic strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Adult patient with a posititive serology BK confirmed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BK positive\n* adult\n* ok to participed to research\n\nExclusion Criteria:\n\n* under guardianship\n* under curatorship\n* opposed to research\n* deprived of liberty'}, 'identificationModule': {'nctId': 'NCT05264259', 'acronym': 'AcMBK', 'briefTitle': 'New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies', 'orgStudyIdInfo': {'id': '8521'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Samira FAFI-KREMER, PUPH', 'role': 'CONTACT', 'email': 'samira.fafi-kremer@chru-strasbourg.fr', 'phone': '0369551438'}], 'facility': 'Service de Virologie - CHU Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Anne-Sophie U GEY', 'role': 'CONTACT', 'email': 'anne-sophie.gey@chru-strasbourg.fr', 'phone': '+33 388116684'}], 'overallOfficials': [{'name': 'Samira FAFI-KREMER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Strasbourg, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}