HCV InfectionPhase 4ECLIPSENCT04235049
Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations (ECLIPSE)
A Phase 4 study testing Glecaprevir/pibrentasvir in people with HCV Infection, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The development of directly acting antivirals (DAA) has dramatically improved the cure rate of HCV treatment. People who experience incarceration are disproportionately infected and often involved in ongoing transmission of disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV Infection
- What is being tested?
- Glecaprevir/pibrentasvir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 30 Oct 2024
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years old
- Able and willing to sign informed consent
- For the community linkage arm: Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).
- For the community linkage arm: ineligible for treatment through the prison/jail without a known sentence longer than 9 months, as of consent date
- For the in-prison arm: Achievement of SVR through the previous standard of care treatment through the DOC
Who cannot join
- Decompensated cirrhosis (Child-Pugh B or C)
- Pregnant or breastfeeding women
- For community linkage arm: Prior treatment with a direct acting antiviral regimen
- For community linkage arm: Any co-medications that are contraindicated or not recommended for concomitant use with glecaprevir-pibrentasvir
- Poor venous access not allowing screening laboratory collection
- Have any condition that the investigator considers a contraindication to study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore City Detention Center
Baltimore, Maryland, 21202
About this study
Official title: Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations
Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The development of directly acting antivirals (DAA) has dramatically improved the cure rate of HCV treatment. People who experience incarceration are disproportionately infected and often involved in ongoing transmission of disease. However, despite availability of effective treatment, people who experience incarceration are often unable to access this curative therapy, and are often not readily engaged in medical care upon release. This perpetuates transmission and progression of disease in an incredibly high risk, marginalized population. Therefore, in order to effectively eliminate HCV, it is imperative that the epidemic of HCV in prisons is addressed, and that models of care are established for treatment of HCV in incarcerated individuals, both during and after incarceration.
As such, the investigators propose a comprehensive model of care to engage incarcerated individuals in treatment of HCV upon release from prison. This care is provided in conjunction with collocated services to prevent HCV reinfection, including opioid agonist therapy. This pilot trial will demonstrate whether a comprehensive model of care can effectively cure HCV in recently incarcerated individuals, while simultaneously treating opioid use disorder and preventing HCV reinfection.
- Conditions
- HCV Infection
- Being tested
- Glecaprevir/pibrentasvir
- Keywords
- HCV infection, Incarcerated individuals
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glecaprevir/pibrentasvirDrug
Treatment for HCV Infection
| Study group | Role | What they receive |
|---|---|---|
| In prison treatment arm | No intervention | Of patients who achieved SVR, 100 inmates will be enrolled for long-term monitoring for re-infection after they have completed treatment. Patients will be seen every 6 months to test for reinfection, however they will not be subject to any medical or behavioral interventions through the study team. Limited opioid agonist therapy may be available as per the standard practice of the DOC, however syringe exchange and other harm reduction services will not be accessible to inmates, per DOC policy. |
| Community Linkage - Rapid Initiation Arm | Active comparator | The rapid initiation group will receive HCV medication immediately upon release from prison/jail. Receives: Drug: Glecaprevir/pibrentasvir |
| Community Linkage - Clinic-Based Initiation Arm | Active comparator | The group will receive medication after attending first ANCHOR clinic visit. Receives: Drug: Glecaprevir/pibrentasvir |
| In prison - Retrospective Review | No intervention | a retrospective review of de-identified available data provided by the DOC for all patients previously treated with DAAs through standard of care in the DOC will be reviewed for rates of SVR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response (SVR) in the community linkage arm
Absence of plasma HCV RNA levels 70 days or greater after completing direct acting antiviral therapy.
Measured: 6 months after treatment
Secondary outcomes (5)
Retrospective rates of SVR in the In prison arm
Absence of plasma HCV RNA levels 70 days or greater after completing direct acting antiviral therapy.
Measured: 6 months after treatment
Treatment Initiation Rates
Rates of treatment initiation in the CL arm (defined as taking one dose of direct acting antiviral)
Measured: 6 months
OAT uptake Rates
Rates of OAT uptake in the CL arm (defined as completion of OAT induction)
Measured: 12 months
HCV Reinfection Rates
Reinfection (defined as documentation of infection with a different HCV genotype than at baseline before treatment, or if the same genotype, viremia after SVR determination, or phylogenetic analysis shows a different virus strain than the pre treatment baseline strain)
Measured: 24 months
Comparison between Rapid Initiation and Clinic-base Initiation
Comparative efficacy of rapid initiation (RI) and clinic-based initiation (CB) arms, comparing the rates of SVR in patients who were randomized to the RI arm compared to patients randomized to the CB arm.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Oct 2021 (estimated)
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Oct 2024 (estimated)
Why it stopped: Department of Corrections unable to support study at this time and find agreement on publication issue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV InfectionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Maryland Department of Public Safety and Correctional Services
- Responsible party
- Principal investigator, Elana Rosenthal, University of Maryland, Baltimore
- Investigators
- Elana Rosenthal, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235049
- Sponsor's protocol ID
- HP-00088498
- Acronym
- ECLIPSE
- Status last verified
- Apr 2021
- First submitted
- 10 Jan 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations
- ClinicalTrials.gov ID
- NCT04235049
- Acronym / sponsor ID
- ECLIPSE / HP-00088498
- Conditions
- HCV Infection
- Keywords
- HCV infection, Incarcerated individuals
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Department of Corrections unable to support study at this time and find agreement on publication issue.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Maryland Department of Public Safety and Correctional Services
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 21 Jan 2020 (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.
Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The development of directly acting antivirals (DAA) has dramatically improved the cure rate of HCV treatment. People who experience incarceration are disproportionately infected and often involved in ongoing transmission of disease. However, despite availability of effective treatment, people who experience incarceration are often unable to access this curative therapy, and are often not readily engaged in medical care upon release. This perpetuates transmission and progression of disease in an incredibly high risk, marginalized population. Therefore, in order to effectively eliminate HCV, it is imperative that the epidemic of HCV in prisons is addressed, and that models of care are established for treatment of HCV in incarcerated individuals, both during and after incarceration.
As such, the investigators propose a comprehensive model of care to engage incarcerated individuals in treatment of HCV upon release from prison. This care is provided in conjunction with collocated services to prevent HCV reinfection, including opioid agonist therapy. This pilot trial will demonstrate whether a comprehensive model of care can effectively cure HCV in recently incarcerated individuals, while simultaneously treating opioid use disorder and preventing HCV reinfection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| In prison treatment arm | No intervention | –Of patients who achieved SVR, 100 inmates will be enrolled for long-term monitoring for re-infection after they have completed treatment. Patients will be seen every 6 months to test for reinfection, however they will not be subject to any medical or behavioral interventions through the study team. Limited opioid agonist therapy may be available as per the standard practice of the DOC, however syringe exchange and other harm reduction services will not be accessible to inmates, per DOC policy. |
| Community Linkage - Rapid Initiation Arm | Active comparator | Drug: Glecaprevir/pibrentasvirThe rapid initiation group will receive HCV medication immediately upon release from prison/jail. |
| Community Linkage - Clinic-Based Initiation Arm | Active comparator | Drug: Glecaprevir/pibrentasvirThe group will receive medication after attending first ANCHOR clinic visit. |
| In prison - Retrospective Review | No intervention | –a retrospective review of de-identified available data provided by the DOC for all patients previously treated with DAAs through standard of care in the DOC will be reviewed for rates of SVR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than or equal to 18 years old
- Able and willing to sign informed consent
- For the community linkage arm: Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).
- For the community linkage arm: ineligible for treatment through the prison/jail without a known sentence longer than 9 months, as of consent date
- For the in-prison arm: Achievement of SVR through the previous standard of care treatment through the DOC
Key exclusion criteria (6 listed)
- Decompensated cirrhosis (Child-Pugh B or C)
- Pregnant or breastfeeding women
- For community linkage arm: Prior treatment with a direct acting antiviral regimen
- For community linkage arm: Any co-medications that are contraindicated or not recommended for concomitant use with glecaprevir-pibrentasvir
- Poor venous access not allowing screening laboratory collection
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/pibrentasvirTreatment for HCV Infection | Drug | Community Linkage - Clinic-Based Initiation Arm, Community Linkage - Rapid Initiation Arm |
Primary outcome
Sustained Virologic Response (SVR) in the community linkage arm
Time frame: 6 months after treatment
Absence of plasma HCV RNA levels 70 days or greater after completing direct acting antiviral therapy.
5 secondary outcomes
Retrospective rates of SVR in the In prison arm
Time frame: 6 months after treatment
Treatment Initiation Rates
Time frame: 6 months
OAT uptake Rates
Time frame: 12 months
HCV Reinfection Rates
Time frame: 24 months
Comparison between Rapid Initiation and Clinic-base Initiation
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
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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.
Elana Rosenthal, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glecaprevir/pibrentasvir in people with HCV Infection, run by University of Maryland, Baltimore 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 6 May 2021. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Sustained Virologic Response (SVR) in the community linkage arm (time frame: 6 months after treatment). 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 6 May 2021.