PTSDPhase 2/3NCT05446857
Glecaprevir/Pibrentasvir for the Treatment of PTSD
A Phase 2/3 study testing Glecaprevir / Pibrentasvir Pill in people with PTSD, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
Trial summary
An open-label pilot study 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). Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- PTSD
- What is being tested?
- Glecaprevir / Pibrentasvir Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 15 Apr 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-70 years
- Weight ≥ 45 kg
- PTSD as determined by the CAPS within seven days of enrollment.
- Eligible for Veterans Affairs healthcare.
- If of 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
White River Junction VAMC
White River Junction, Vermont, 05009
About this study
An open-label pilot study 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).
Read the detailed description
To perform an open-label pilot study (N=10) 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). The specific research described in this proposal is intended to pilot GLE/PIB for N=10 patients with PTSD in the absence of HCV.
Primary Aims:
Aim 1: Determine the feasibility of testing GLE/PIB for PTSD symptoms. Aim 2: Determine the feasibility of testing GLE/PIB for functioning among patients with PTSD.
Aim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV.
Exploratory Aim: Investigate the possible biological mechanism of GLE/PIB for PTSD via blood bio-marker analyses.
- Conditions
- PTSD
- Being tested
- Glecaprevir / Pibrentasvir Pill
- Keywords
- PTSD, Antiviral, Hepatitis C
- Medical subject headings
- Stress Disorders, Post-Traumatic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glecaprevir / Pibrentasvir PillDrug
Also called Mavyret
Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Drug | Experimental | All enrolled participants will receive Glecaprevir/Pibrentasvir Receives: Drug: Glecaprevir / Pibrentasvir Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)
Queries the frequency and intensity of symptoms of Post-traumatic Stress Disorder (PTSD). The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.
Measured: Change from Baseline CAPS score at 8 weeks
World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)
A 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-180 with a higher score indicating worse functioning.
Measured: Change from Baseline WHODAS score at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Apr 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Bradley Watts, White River Junction Veterans Affairs Medical Center
- Investigators
- Bradley V Watts, MD, MPH, Principal investigator, White River Junction Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446857
- Sponsor's protocol ID
- 1673711
- Status last verified
- Aug 2024
- First submitted
- 1 Jul 2022
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glecaprevir/Pibrentasvir for the Treatment of PTSD
- ClinicalTrials.gov ID
- NCT05446857
- Acronym / sponsor ID
- 1673711
- Conditions
- PTSD
- Keywords
- PTSD, Antiviral, Hepatitis C
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label pilot study 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).
Detailed description
To perform an open-label pilot study (N=10) 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). The specific research described in this proposal is intended to pilot GLE/PIB for N=10 patients with PTSD in the absence of HCV.
Primary Aims:
Aim 1: Determine the feasibility of testing GLE/PIB for PTSD symptoms. Aim 2: Determine the feasibility of testing GLE/PIB for functioning among patients with PTSD.
Aim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV.
Exploratory Aim: Investigate the possible biological mechanism of GLE/PIB for PTSD via blood bio-marker analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Active Drug | Experimental | Drug: Glecaprevir / Pibrentasvir PillAll enrolled participants will receive Glecaprevir/Pibrentasvir |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 19-70 years
- Weight ≥ 45 kg
- PTSD as determined by the CAPS within seven days of enrollment.
- Eligible for Veterans Affairs healthcare.
- If of childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glecaprevir / Pibrentasvir PillAlso: MavyretGlecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks. | Drug | Active Drug |
Primary outcome
Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)
Time frame: Change from Baseline CAPS score at 8 weeks
Queries the frequency and intensity of symptoms of Post-traumatic Stress Disorder (PTSD). The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.
World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)
Time frame: Change from Baseline WHODAS score at 8 weeks
A 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-180 with a higher score indicating worse functioning.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley V Watts, MD, MPH principal investigator
White River Junction Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Glecaprevir / Pibrentasvir Pill in people with PTSD, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5) (time frame: Change from Baseline CAPS score at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.