Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
NCT ID: NCT05637879
Last Updated: 2025-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
92 participants
INTERVENTIONAL
2023-12-18
2026-09-30
Brief Summary
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Detailed Description
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Primary Aims:
Aim 1: Determine the efficacy of GLE/PIB for PTSD symptom improvement. Aim 2: Determine the efficacy of GLE/PIB for functioning improvement among patients with PTSD.
Aim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Drug
Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.
Glecaprevir/pibrentasvir
Direct-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection
Placebo
Placebo, 3 oral tablets once daily for 8 weeks.
Placebo
Compounded, inactive pill equal in appearance to active study drug
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
19 Years
70 Years
ALL
No
Sponsors
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White River Junction Veterans Affairs Medical Center
FED
Responsible Party
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Bradley Watts
Staff Psychiatrist
Principal Investigators
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Bradley V Watts, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
US Department of Veterans Affairs
Locations
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White River Junction VAMC
White River Junction, Vermont, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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W81XWH22C0147
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1698661
Identifier Type: -
Identifier Source: org_study_id
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