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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05637879). StuddyBuddy aggregates publicly available trial information.