RECRUITING

Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

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Conditions

PTSDAntiviralHepatitis C

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-12-18
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05637879

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 19-70 years
  2. 2. Weight ≥ 45 kg
  3. 3. Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment
  4. 4. Eligible for Veterans Affairs healthcare
  5. 5. If person with childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required.
  6. 6. Able to read, understand, and sign the informed consent document.
  7. 1. Pregnant or lactating person
  8. 2. Moderate or severe hepatic impairment (Child-Pugh B or C)
  9. 3. History of prior hepatic decompensation
  10. 4. Current use of drugs listed as having significant drug interactions on prescribing label
  11. 5. Advanced liver disease
  12. 6. Current or prior hepatitis B infection
  13. 7. Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor
  14. 8. Current HCV infection
  15. 9. Current psychosis or mania
  16. 10. Significant suicidal ideation
  17. 11. Unstable medical conditions
  18. 12. Current severe alcohol or substance use disorder (excluding nicotine)
  19. 13. Evidence-based PTSD psychotherapy changes in the past two months
  20. 14. Evidence-based PTSD medication changes in the past two months
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Bradley V Watts, MD, MPH
CONTACT
802-295-9363
bradley.watts@va.gov
Emily Colon, MS
CONTACT
802-295-9363
emily.colon@va.gov

Principal Investigator

Bradley V Watts, MD, MPH
PRINCIPAL_INVESTIGATOR
US Department of Veterans Affairs

Study Locations (Sites)

White River Junction VAMC
White River Junction, Vermont, 05001
United States

Collaborators and Investigators

Sponsor: White River Junction Veterans Affairs Medical Center

  • Bradley V Watts, MD, MPH, PRINCIPAL_INVESTIGATOR, US Department of Veterans Affairs

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-18
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2023-12-18
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • PTSD
  • Antiviral
  • Hepatitis C

Additional Relevant MeSH Terms

  • PTSD