[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488266":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":31,"studyPopulation":18,"armGroups":32,"interventions":45,"overallOfficials":57,"centralContacts":62,"locations":72,"responsibleParty":92,"collaborators":18,"id":95,"slug":18,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":18,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":18,"studyType":107,"phases":108,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":75,"whyStopped":18,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"White River Junction Veterans Affairs Medical Center","FED",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)","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.","Change from Baseline CAPS score at 8 weeks",[14],{"measure":15,"description":16,"timeFrame":17},"World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)","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.","Change from Baseline WHODAS score at 8 weeks",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","Blinded placebo-controlled randomized trial","TREATMENT",{"masking":25,"maskingDescription":18,"whoMasked":26},"QUADRUPLE",[27,28,29,30],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","N=92 patients with posttraumatic stress disorder (PTSD) will be enrolled into a double-blind randomized placebo-controlled trial to further investigate glecaprevir\u002Fpibrentasvir (GLE\u002FPIB), a direct acting antiviral (DAA) that has been associated with PTSD symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV). The research is intended to test the efficacy of GLE\u002FPIB for PTSD symptom improvement in the absence of HCV.\n\nPrimary Aims:\n\nAim 1: Determine the efficacy of GLE\u002FPIB for PTSD symptom improvement. Aim 2: Determine the efficacy of GLE\u002FPIB for functioning improvement among patients with PTSD.\n\nAim 3: Assess the safety and tolerability of GLE\u002FPIB treatment for patients with PTSD in the absence of HCV.",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Active Drug","ACTIVE_COMPARATOR","Glecaprevir 100 mg\u002FPibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.",[38],"Drug: Glecaprevir\u002Fpibrentasvir",{"label":40,"type":41,"description":42,"interventionNames":43},"Placebo","PLACEBO_COMPARATOR","Placebo, 3 oral tablets once daily for 8 weeks.",[44],"Other: Placebo",[46,53],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DRUG","Glecaprevir\u002Fpibrentasvir","Direct-acting antiviral, Food \\& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection",[34],[52],"Mavyret",{"type":54,"name":40,"description":55,"armGroupLabels":56,"otherNames":18},"OTHER","Compounded, inactive pill equal in appearance to active study drug",[40],[58],{"name":59,"affiliation":60,"role":61},"Bradley V Watts, MD, MPH","US Department of Veterans Affairs","PRINCIPAL_INVESTIGATOR",[63,68],{"name":59,"role":64,"phone":65,"phoneExt":66,"email":67},"CONTACT","802-295-9363","5235","bradley.watts@va.gov",{"name":69,"role":64,"phone":65,"phoneExt":70,"email":71},"Emily Colon, MS","6131","emily.colon@va.gov",[73],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"White River Junction VAMC","RECRUITING","White River Junction","Vermont","05001","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-72.31926,43.64896,{"lat":85,"lon":84},[88,91],{"name":89,"role":64,"phone":65,"phoneExt":66,"email":90},"Bradley V Watts, MD","bradley.v.watts@dartmouth.edu",{"name":89,"role":61,"phone":18,"phoneExt":18,"email":18},{"type":61,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Bradley Watts","Staff Psychiatrist","100488266",false,"NCT05637879","Glecaprevir\u002FPibrentasvir for Post-traumatic Stress Disorder","Randomized Controlled Trial of Glecaprevir\u002FPibrentasvir for the Treatment of Post-traumatic Stress Disorder","Inclusion Criteria:\n\n1. Age 19-70 years\n2. Weight ≥ 45 kg\n3. Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment\n4. Eligible for Veterans Affairs healthcare\n5. If person with 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 (unable to participate) 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\u002FPIB or HCV NS5A inhibitor AND NS3\u002F4A 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","ALL","19 Years","70 Years",{"count":105,"type":106},92,"ESTIMATED","INTERVENTIONAL",[109,110],"PHASE2","PHASE3","A double-blind randomized placebo-controlled trial to further investigate glecaprevir\u002Fpibrentasvir (GLE\u002FPIB), 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).",[113],"PTSD",[113,115,116],"Antiviral","Hepatitis C","2025-04-18",{"date":119,"type":120},"2025-04-24","ACTUAL",{"date":122,"type":120},"2023-12-18",{"date":124,"type":106},"2026-09-30",{"name":5,"class":6},1]