Glecaprevir/Pibrentasvir for the Treatment of PTSD

NCT ID: NCT05446857

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-04-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Drug

All enrolled participants will receive Glecaprevir/Pibrentasvir

Group Type: EXPERIMENTAL

Glecaprevir / Pibrentasvir Pill

Intervention Type: DRUG

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

Interventions

Glecaprevir / Pibrentasvir Pill

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

Intervention Type: DRUG

Other Intervention Names

Mavyret

Eligibility Criteria

Inclusion Criteria

1. Age 19-70 years

2. Weight ≥ 45 kg

3. PTSD as determined by the CAPS within seven days of enrollment.

4. Eligible for Veterans Affairs healthcare.

5. If of 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 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

White River Junction Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Bradley Watts

Staff Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bradley V Watts, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

White River Junction Veterans Affairs Medical Center

Locations

White River Junction VAMC

White River Junction, Vermont, United States

Countries

United States

Other Identifiers

1673711

Identifier Type: -

Identifier Source: org_study_id