Actively Recruiting

Phase 2
Phase 3
Age: 19Years - 70Years
All Genders
NCT05637879

Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

Led by White River Junction Veterans Affairs Medical Center · Updated on 2025-04-24

92

Participants Needed

1

Research Sites

145 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

Who Can Participate

Age: 19Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19-70 years
  • Weight at least 45 kg
  • Diagnosed with PTSD using CAPS-5 within seven days before enrollment
  • Eligible for Veterans Affairs healthcare
  • If able to bear children, must use effective birth control or abstain
  • Able to read, understand, and sign informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Moderate or severe liver impairment (Child-Pugh B or C)
  • History of liver failure
  • Using drugs with significant interactions listed on the study drug label
  • Advanced liver disease
  • Current or past hepatitis B infection
  • Previous use of GLE/PIB or certain hepatitis C drugs
  • Current hepatitis C infection
  • Current psychosis or mania
  • Significant suicidal thoughts
  • Unstable medical conditions
  • Severe alcohol or substance use disorder (excluding nicotine)
  • Changes in PTSD psychotherapy in past two months
  • Changes in PTSD medications in past two months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

White River Junction VAMC

White River Junction, Vermont, United States, 05001

Actively Recruiting

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Research Team

B

Bradley V Watts, MD, MPH

CONTACT

E

Emily Colon, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder | DecenTrialz