Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-28 @ 4:47 PM
Study NCT ID:
NCT05446857
Status:
COMPLETED
Last Update Posted:
2024-08-29
First Post:
2022-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glecaprevir/Pibrentasvir for the Treatment of PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000612853', 'term': 'glecaprevir'}, {'id': 'C000622691', 'term': 'pibrentasvir'}, {'id': 'C000654128', 'term': 'glecaprevir and pibrentasvir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)', 'timeFrame': 'Change from Baseline CAPS score at 8 weeks', 'description': 'Queries the frequency and intensity of symptoms of Post-traumatic Stress Disorder (PTSD). The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.'}, {'measure': 'World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)', 'timeFrame': 'Change from Baseline WHODAS score at 8 weeks', 'description': 'A 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-180 with a higher score indicating worse functioning.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PTSD', 'Antiviral', 'Hepatitis C'], 'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'An open-label pilot study to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with posttraumatic stress disorder (PTSD) symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV).', 'detailedDescription': 'To perform an open-label pilot study (N=10) to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with posttraumatic stress disorder (PTSD) symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV). The specific research described in this proposal is intended to pilot GLE/PIB for N=10 patients with PTSD in the absence of HCV.\n\nPrimary Aims:\n\nAim 1: Determine the feasibility of testing GLE/PIB for PTSD symptoms. Aim 2: Determine the feasibility of testing GLE/PIB for functioning among patients with PTSD.\n\nAim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV.\n\nExploratory Aim: Investigate the possible biological mechanism of GLE/PIB for PTSD via blood bio-marker analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Summary\n\n1. Age 19-70 years\n2. Weight ≥ 45 kg\n3. PTSD as determined by the CAPS within seven days of enrollment.\n4. Eligible for Veterans Affairs healthcare.\n5. If of childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required.\n6. Able to read, understand, and sign the informed consent document.\n\nExclusion Criteria:\n\n1. Pregnant or lactating person\n2. Moderate or severe hepatic impairment (Child-Pugh B or C)\n3. History of prior hepatic decompensation\n4. Current use of drugs listed as having significant drug interactions on prescribing label\n5. Advanced liver disease\n6. Current or prior hepatitis B infection\n7. Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor\n8. Current HCV infection\n9. Current psychosis or mania\n10. Significant suicidal ideation\n11. Unstable medical conditions\n12. Current severe alcohol or substance use disorder (excluding nicotine)\n13. Evidence-based PTSD psychotherapy changes in the past two months\n14. Evidence-based PTSD medication changes in the past two months'}, 'identificationModule': {'nctId': 'NCT05446857', 'briefTitle': 'Glecaprevir/Pibrentasvir for the Treatment of PTSD', 'organization': {'class': 'FED', 'fullName': 'White River Junction Veterans Affairs Medical Center'}, 'officialTitle': 'Glecaprevir/Pibrentasvir for the Treatment of PTSD', 'orgStudyIdInfo': {'id': '1673711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Drug', 'description': 'All enrolled participants will receive Glecaprevir/Pibrentasvir', 'interventionNames': ['Drug: Glecaprevir / Pibrentasvir Pill']}], 'interventions': [{'name': 'Glecaprevir / Pibrentasvir Pill', 'type': 'DRUG', 'otherNames': ['Mavyret'], 'description': 'Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.', 'armGroupLabels': ['Active Drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05009', 'city': 'White River Junction', 'state': 'Vermont', 'country': 'United States', 'facility': 'White River Junction VAMC', 'geoPoint': {'lat': 43.64896, 'lon': -72.31926}}], 'overallOfficials': [{'name': 'Bradley V Watts, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'White River Junction Veterans Affairs Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'White River Junction Veterans Affairs Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Psychiatrist', 'investigatorFullName': 'Bradley Watts', 'investigatorAffiliation': 'White River Junction Veterans Affairs Medical Center'}}}}