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Not Yet Recruiting
NCT05637879
Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
Conditions: Ptsd
Sex: All
Ages: 19 Years – 70 Years
Phase: PHASE2, PHASE3
Enrollment: 92
Sponsor: White River Junction Veterans Affairs Medical Center
Location: United States
Summary
A double-blind randomized placebo-controlled trial 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).
Eligibility Criteria
Inclusion Criteria:Age 19-70 yearsWeight ≥ 45 kgDiagnosed with PTSD as determined by the CAPS-5 within seven days of enrollmentEligible for Veterans Affairs healthcareIf person with childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required.Able to read, understand, and sign the informed consent document.Exclusion (unable to participate) Criteria:Pregnant or lactating personModerate or severe hepatic impairment (Child-Pugh B or C)History of prior hepatic decompensationCurrent use of drugs listed as having significant drug interactions on prescribing labelAdvanced liver diseaseCurrent or prior hepatitis B infectionPrior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitorCurrent HCV infectionCurrent psychosis or maniaSignificant suicidal ideationUnstable medical conditionsCurrent severe alcohol or substance use disorder (excluding nicotine)Evidence-based PTSD psychotherapy changes in the past two monthsEvidence-based PTSD medication changes in the past two months
Source: ClinicalTrials.gov (NCT05637879). StuddyBuddy aggregates publicly available trial information.