Glecaprevir/Pibrentasvir for the Treatment of PTSD

NCT05446857 | Completed Phase 2 FDA Drug

• 1 other identifier: 1673711
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

PTSD

Keywords

PTSD; Antiviral; Hepatitis C

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Active Drug

EXPERIMENTAL

All enrolled participants will receive Glecaprevir/Pibrentasvir

Drug: Glecaprevir / Pibrentasvir Pill

Interventions

Glecaprevir / Pibrentasvir Pill DRUG

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

Also known as: Mavyret

Active Drug

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19-70 years
• Weight ≥ 45 kg
• PTSD as determined by the CAPS within seven days of enrollment.
• Eligible for Veterans Affairs healthcare.
• If of 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.

You may not qualify if:

• Pregnant or lactating person
• Moderate or severe hepatic impairment (Child-Pugh B or C)
• History of prior hepatic decompensation
• Current use of drugs listed as having significant drug interactions on prescribing label
• Advanced liver disease
• Current or prior hepatitis B infection
• Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor
• Current HCV infection
• Current psychosis or mania
• Significant suicidal ideation
• Unstable medical conditions
• Current severe alcohol or substance use disorder (excluding nicotine)
• Evidence-based PTSD psychotherapy changes in the past two months
• Evidence-based PTSD medication changes in the past two months

Sponsors & Collaborators

• White River Junction Veterans Affairs Medical Center: lead

Study Sites (1)

White River Junction VAMC

White River Junction, Vermont, 05009, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Hepatitis C

Interventions

glecaprevir; pibrentasvir; glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Bradley V Watts, MD, MPH

  White River Junction Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychiatrist

Model Details: Pilot study

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 7, 2022
• Study Start: April 1, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)