Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-23 @ 3:34 PM
Study NCT ID:
NCT06682234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-01
First Post:
2024-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Obeldesivir as Postexposure Prophylaxis for Filovirus Diseases Virus Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2024-11-07', 'studyFirstSubmitQcDate': '2024-11-07', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Experiencing Serious Adverse Events (SAEs)', 'timeFrame': 'First dose date up to 29 Days'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants with Symptomatic Filovirus Disease by Day 29', 'timeFrame': 'Up to 29 Days'}, {'measure': 'Proportion of Participants with Polymerase Chain Reaction (PCR)-Confirmed Filovirus Disease Infections by Day 29', 'timeFrame': 'Up to 29 Days'}, {'measure': 'Proportion of Participants with All-Cause Death by Day 29', 'timeFrame': 'Up to 29 Days'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Filovirus Disease', 'Postexposure Prophylaxis for Filovirus Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study?nctid=NCT06682234', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to learn more about the study drug, obeldesivir (ODV), and how safe and effective it is preventing Filovirus disease in participants with known or suspected exposure to Filovirus disease.\n\nThe primary objective is to evaluate the safety and tolerability of ODV for Ebola virus (EBOV), Sudan virus (SUDV), and MARV postexposure prophylaxis (PEP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Able to understand and give written informed consent and comply with treatment and follow up.\n* Individuals who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception\n* Known or suspected high-risk exposure to Ebola virus (EBOV), Sudan virus (SUDV), or Marburg virus (MARV) within 21 days of Day 1. High-risk exposure may include the following:\n\n 1. Direct contact with bodily fluids from a confirmed case.\n 2. Needle stick injury with a needle potentially contaminated with virus.\n 3. Prolonged exposure to an individual with EBOV, SUDV, or MARV infection or disease without (adequate) personal protective equipment.\n\nKey Exclusion Criteria:\n\n* Individuals with plans to breastfeed during the study period and 21 days following the last dose of study intervention. World Health Organization guidance on breastfeeding should be followed.\n* Known hypersensitivity to the study intervention, its metabolites, or formulation excipient.\n* Known EBOV, SUDV, or MARV reverse transcriptase-polymerase chain reaction (RT-PCR) positivity or symptomatic filovirus disease as attributed by the investigator.\n* Known moderate or severe renal impairment or known estimated glomerular filtration rate (eGFR) \\< 60 mL/min/1.73 m\\^2.\n* Decompensated cirrhosis (Child-Pugh Class C), acute liver injury/failure (eg, new onset \\[\\< 2 weeks\\] of easy bruising, jaundice, ascites, hepatic encephalopathy, asterixis), and/or known alanine aminotransferase ≥5 × upper limit of normal.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06682234', 'briefTitle': 'Study of Obeldesivir as Postexposure Prophylaxis for Filovirus Diseases Virus Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2, Single-Arm Study of Obeldesivir for Postexposure Prophylaxis of Filovirus Diseases', 'orgStudyIdInfo': {'id': 'GS-US-719-7450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obeldesivir (ODV)', 'description': 'Participants will receive ODV for 10 days', 'interventionNames': ['Drug: obeldesivir']}], 'interventions': [{'name': 'obeldesivir', 'type': 'DRUG', 'otherNames': ['GS-5245'], 'description': 'Tablets administered orally', 'armGroupLabels': ['Obeldesivir (ODV)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gilead Clinical Study Information Center', 'role': 'CONTACT', 'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)'}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}