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Recruiting NCT05637879

Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

Phase II / Phase III Interventional PTSD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Glecaprevir/pibrentasvir, Placebo.
Who it may be relevant to
Registry conditions: PTSD. Basic parameters: 19 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder

Overview

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).

Detailed description

N=92 patients with posttraumatic stress disorder (PTSD) will be enrolled into a double-blind randomized placebo-controlled trial to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with PTSD symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV). The research is intended to test the efficacy of GLE/PIB for PTSD symptom improvement in the absence of HCV.

Primary Aims:

Aim 1: Determine the efficacy of GLE/PIB for PTSD symptom improvement. Aim 2: Determine the efficacy of GLE/PIB for functioning improvement among patients with PTSD.

Aim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV.

Interventions

  • Drug Glecaprevir/pibrentasvir
    Direct-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection
  • Other Placebo
    Compounded, inactive pill equal in appearance to active study drug

Primary outcome measures

  • Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5) [Time frame: Change from Baseline CAPS score at 8 weeks]
Secondary outcome measures (1)
  • World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS) [Time frame: Change from Baseline WHODAS score at 8 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion (unable to participate) Criteria:

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • White River Junction VAMC — White River Junction

Identifiers

NCT: NCT05637879 · 1698661 · W81XWH22C0147

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗