NCT05637879 Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
| NCT ID | NCT05637879 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | White River Junction Veterans Affairs Medical Center |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2023-12-18 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 92 participants in total. It began in 2023-12-18 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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: 1. Age 19-70 years 2. Weight ≥ 45 kg 3. Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment 4. Eligible for Veterans Affairs healthcare 5. If person with childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required. 6. Able to read, understand, and sign the informed consent document. Exclusion (unable to participate) Criteria: 1. Pregnant or lactating person 2. Moderate or severe hepatic impairment (Child-Pugh B or C) 3. History of prior hepatic decompensation 4. Current use of drugs listed as having significant drug interactions on prescribing label 5. Advanced liver disease 6. Current or prior hepatitis B infection 7. Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor 8. Current HCV infection 9. Current psychosis or mania 10. Significant suicidal ideation 11. Unstable medical conditions 12. Current severe alcohol or substance use disorder (excluding nicotine) 13. Evidence-based PTSD psychotherapy changes in the past two months 14. Evidence-based PTSD medication changes in the past two months
Contact & Investigator
Bradley V Watts, MD, MPH
PRINCIPAL INVESTIGATOR
US Department of Veterans Affairs
Frequently Asked Questions
Who can join the NCT05637879 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 70 Years, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05637879 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05637879 currently recruiting?
Yes, NCT05637879 is actively recruiting participants. Contact the research team at bradley.watts@va.gov for enrollment information.
Where is the NCT05637879 trial being conducted?
This trial is being conducted at White River Junction, United States.
Who is sponsoring the NCT05637879 clinical trial?
NCT05637879 is sponsored by White River Junction Veterans Affairs Medical Center. The principal investigator is Bradley V Watts, MD, MPH at US Department of Veterans Affairs. The trial plans to enroll 92 participants.
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