Glecaprevir/Pibrentasvir for the Treatment of PTSD

PTSD Clinical Trial

Official title:

Glecaprevir/Pibrentasvir for the Treatment of PTSD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05446857
• Other study ID #: 1673711
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: White River Junction Veterans Affairs Medical Center
• Contact: Bradley V Watts, MD, MPH
• Phone: 802-295-9363
• Email: bradley.watts[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria Summary

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

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	White River Junction VAMC	White River Junction	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
White River Junction Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)	Queries the frequency and intensity of symptoms of Post-traumatic Stress Disorder (PTSD). The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.	Change from Baseline CAPS score at 8 weeks
Primary	World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)	A 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-180 with a higher score indicating worse functioning.	Change from Baseline WHODAS score at 8 weeks