Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: PTSD

In brief

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).

Key facts

Study ID

NCT05637879

Run by

White River Junction Veterans Affairs Medical Center

People needed

92

Starts

2023-12-18

Expected to finish

2026-09-30

Last updated by the study team

2025-04-24

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 19-70 years
• Weight ≥ 45 kg
• Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment
• Eligible for Veterans Affairs healthcare
• If 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 person
• Moderate or severe hepatic impairment (Child-Pugh B or C)
• History of prior hepatic decompensation
• Current use of drugs listed as having significant drug interactions on prescribing label
• Advanced liver disease
• Current or prior hepatitis B infection
• Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor
• Current HCV infection
• Current psychosis or mania
• Significant suicidal ideation
• Unstable medical conditions
• Current severe alcohol or substance use disorder (excluding nicotine)
• Evidence-based PTSD psychotherapy changes in the past two months
• Evidence-based PTSD medication changes in the past two months

Where it is running

• White River Junction VAMC — White River Junction, Vermont, United States (enrolling)

Full record on ClinicalTrials.gov

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