Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT05446857
Eligibility Criteria:
Inclusion Criteria Summary
1. Age 19-70 years
2. Weight ≥ 45 kg
3. PTSD as determined by the CAPS within seven days of enrollment.
4. Eligible for Veterans Affairs healthcare.
5. If of childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required.
6. Able to read, understand, and sign the informed consent document.
Exclusion Criteria:
1. Pregnant or lactating person
2. Moderate or severe hepatic impairment (Child-Pugh B or C)
3. History of prior hepatic decompensation
4. Current use of drugs listed as having significant drug interactions on prescribing label
5. Advanced liver disease
6. Current or prior hepatitis B infection
7. Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor
8. Current HCV infection
9. Current psychosis or mania
10. Significant suicidal ideation
11. Unstable medical conditions
12. Current severe alcohol or substance use disorder (excluding nicotine)
13. Evidence-based PTSD psychotherapy changes in the past two months
14. Evidence-based PTSD medication changes in the past two months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT05446857
Study Brief:
Protocol Section:
NCT05446857