Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

NCT05637879 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 1698661W81XWH22C0147
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind randomized placebo-controlled trial 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 (1)

• 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

Secondary Outcomes (1)

• World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)

  Change from Baseline WHODAS score at 8 weeks

Study Arms (2)

Active Drug

ACTIVE COMPARATOR

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

Drug: Glecaprevir/pibrentasvir

Placebo

PLACEBO COMPARATOR

Placebo, 3 oral tablets once daily for 8 weeks.

Other: Placebo

Interventions

Glecaprevir/pibrentasvir DRUG

Direct-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection

Also known as: Mavyret

Active Drug

Placebo OTHER

Compounded, inactive pill equal in appearance to active study drug

Placebo

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
• Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment
• Eligible for Veterans Affairs healthcare
• If person with 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.
• 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

Sponsors & Collaborators

• White River Junction Veterans Affairs Medical Center: lead

Study Sites (1)

White River Junction VAMC

White River Junction, Vermont, 05001, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Hepatitis C

Interventions

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

  US Department of Veterans Affairs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bradley V Watts, MD, MPH

CONTACT

802-295-9363; bradley.watts@va.gov

Emily Colon, MS

CONTACT

802-295-9363; emily.colon@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychiatrist

Model Details: Blinded placebo-controlled randomized trial

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 6, 2022
• Study Start: December 18, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 24, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)