RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Glecaprevir/pibrentasvir
Direct-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection
OTHER
Placebo
Compounded, inactive pill equal in appearance to active study drug
Locations (1)
White River Junction VAMC
White River Junction, Vermont, United States