Clincosm LogoSign in Get a demo

Glecaprevir/Pibrentasvir for the Treatment of PTSD

Sponsor
White River Junction Veterans Affairs Medical Center (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT05446857
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
23
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Glecaprevir / Pibrentasvir Pill
 Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pilot studyPilot study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Glecaprevir/Pibrentasvir for the Treatment of PTSD
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active Drug

All enrolled participants will receive Glecaprevir/Pibrentasvir

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Administered PTSD Scale version 5 (CAPS-5) [Baseline: within 10 days prior to drug initiation]

      Queries the frequency and intensity of symptoms of 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.

    2. Clinical Administered PTSD Scale version 5 (CAPS-5) [Post treatment: 7 days after medication completion]

      Queries the frequency and intensity of symptoms of 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.

    3. World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS) [Baseline: within 10 days prior to drug initiation]

      The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is 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 0-100 with a higher score indicating worse functioning.

    4. World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS) [Post treatment: 7 days after medication completion]

      The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is 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 0-100 with a higher score indicating worse functioning.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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 VA healthcare.

    5. If female 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 Criteria:

    1. Pregnant or lactating woman

    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 (HBV) 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. VA/DoD Clinical Practice Guideline first-line psychotherapy changes in the past two months

    14. Evidence-based PTSD medication changes in the past two months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 White River Junction VAMC White River Junction Vermont United States 05009

    Sponsors and Collaborators

    • White River Junction Veterans Affairs Medical Center

    Investigators

    • Principal Investigator: Bradley V Watts, MD, MPH, White River Junction Veterans Affairs Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bradley Watts, Staff Psychiatrist, White River Junction Veterans Affairs Medical Center
    ClinicalTrials.gov Identifier:
    NCT05446857
    Other Study ID Numbers:
    • 1673711
    First Posted:
    Jul 7, 2022
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Bradley Watts, Staff Psychiatrist, White River Junction Veterans Affairs Medical Center
    ptsd, antiviral, Hepatitis C
    Additional relevant MeSH terms:
    Stress Disorders, Post-Traumatic

    Study Results

    No Results Posted as of Jul 7, 2022