At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 92 target
Drug / intervention
Glecaprevir/pibrentasvir +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
- ✓Age 19-70 years
- ✓Weight at least 45 kg
- ✓Diagnosed with PTSD confirmed by CAPS-5 within seven days of enrollment
- ✓Eligible for Veterans Affairs healthcare
Key exclusion· 14
- ✕Pregnant or lactating
- ✕Moderate or severe hepatic impairment (Child-Pugh B or C)
- ✕History of prior hepatic decompensation
- ✕Current use of drugs with significant interactions per prescribing label
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05637879Phase 3RecruitingUpdate OverdueUpdated 14mo ago · Completion was 6mo agoEnrollment Stalled
Update Overdue
Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder
White River Junction Veterans Affairs Medical Center·interventional·Posted Dec 6, 2022·Updated Apr 24, 2025
In Brief
A Phase 3 clinical trial evaluating Glecaprevir/pibrentasvir and Placebo for PTSD. Currently recruiting, targeting 92 participants across 1 site.
Signals
Enrollment appears stalled
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTSD
CountriesUnited States
Collaborators--
Timeline
Phase 3Recruiting
2023202420252026
First PostedDec 2022
Enrollment StartDec 2023
Primary CompletionDec 2025
TodayJul 2026
Study CompletionSep 2026
First PostedDec 6, 2022
Enrollment StartDec 18, 2023
Primary CompletionDec 31, 2025
Study CompletionSep 30, 2026
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 3.6 years ago
Interventions
Glecaprevir/pibrentasvirdrug
Direct-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection
Placeboother
Compounded, inactive pill equal in appearance to active study drug