Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT04268966
Status:
WITHDRAWN
Last Update Posted:
2020-02-26
First Post:
2020-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019142', 'term': 'Hemorrhagic Fever, Ebola'}], 'ancestors': [{'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018702', 'term': 'Filoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C525733', 'term': 'brincidofovir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2020-02-12', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'To assess the effect of BCV treatment on development of EVD in subjects through 21 days post-initiation of BCV therapy', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'conditions': ['Ebola Virus Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how safe and tolerable Brincidofovir (BCV) is when given for post exposure prophylaxis of Ebola virus disease.', 'detailedDescription': 'The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals have high-risk exposure to Ebola Virus based on CDC definitions\n* Must be able to ingest, absorb and tolerate oral medication\n* As appropriate, must be willing to use adequate methods of contraception during the study and at least 6 months after their last dose of BCV\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04268966', 'acronym': 'BCV EBOV', 'briefTitle': 'An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': 'An Open-Label, Multicenter Study of the Safety and Tolerability of Brincidofovir (CMX001) for Post-Exposure Prophylaxis of Ebola Virus Disease', 'orgStudyIdInfo': {'id': 'CMX001-206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CMX001', 'description': 'Initial dose of 200mg followed by 4 doses of 100mg', 'interventionNames': ['Drug: Brincidofovir']}], 'interventions': [{'name': 'Brincidofovir', 'type': 'DRUG', 'otherNames': ['CMX001'], 'armGroupLabels': ['CMX001']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Food and Drug Administration (FDA)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}