NCT05446857

Glecaprevir/Pibrentasvir for the Treatment of PTSD

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: White River Junction Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

An open-label pilot study 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).

Detailed description

To perform an open-label pilot study (N=10) 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). The specific research described in this proposal is intended to pilot GLE/PIB for N=10 patients with PTSD in the absence of HCV. Primary Aims: Aim 1: Determine the feasibility of testing GLE/PIB for PTSD symptoms. Aim 2: Determine the feasibility of testing GLE/PIB for functioning among patients with PTSD. Aim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV. Exploratory Aim: Investigate the possible biological mechanism of GLE/PIB for PTSD via blood bio-marker analyses.

Conditions

• PTSD

Interventions

Type	Name	Description
DRUG	Glecaprevir / Pibrentasvir Pill	Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-04-15
• Completion: 2024-04-15
• First posted: 2022-07-07
• Last updated: 2024-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study