Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
United States
Vermont
White River Junction VAMC
RECRUITING
White River Junction
Contact Information
Primary
Bradley V Watts, MD, MPH
bradley.watts@va.gov
802-295-9363
Backup
Emily Colon, MS
emily.colon@va.gov
802-295-9363
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 92
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: White River Junction Veterans Affairs Medical Center