NCT05637879 · White River Junction Veterans Affairs Medical Center
Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
What this study is about
A where neither patients nor doctors know which treatment is given randomly assigned compared against an inactive treatment 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).
View original scientific 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 criteria
- (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
Where
- White River Junction, Vermont
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2025 · Source of record for eligibility and locations