Recruiting
Phase 2
Phase 3

Glecaprevir/Pibrentasvir

Sponsor:

White River Junction Veterans Affairs Medical Center

Code:

NCT05637879

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 19 - 70

Healthy Volunteers: Not accepted

Interventions

Glecaprevir/pibrentasvir

Placebo

Study Details

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).

Conditions

PTSD

Study ID

NCT05637879

Start date

Dec 18, 2023

Status verified date

Aug, 2024

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active Drug

Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.

placebo comparator: Placebo

Placebo, 3 oral tablets once daily for 8 weeks.

Interventions

Glecaprevir/pibrentasvir

Direct-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection

Placebo

Compounded, inactive pill equal in appearance to active study drug

Primary outcome measure

  • Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5) [ Time Frame: Change from Baseline CAPS score at 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

White River Junction VAMC

Recruiting

White River Junction, Vermont, United States, 05001

Contacts

Principal Investigator:

Bradley V Watts, MD

More Information

Sponsor

White River Junction Veterans Affairs Medical Center

Last update posted

Apr 24, 2025

Last verified

Aug, 2024

Keywords

  • PTSD
  • Antiviral
  • Hepatitis C

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by White River Junction Veterans Affairs Medical Center on 2025-04-24.