Hepatitis C, ChronicPhase 4CHIPNCT03018353
Curing HCV in Incarcerated Patients
A Phase 4 study testing Patients receiving Sof/Vel (Epclusa) and Navigation services in people with Hepatitis C, Chronic, run by San Francisco Department of Public Health at 1 site in United States.
Trial summary
Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess the feasibility of a HCV treatment program in the San Francisco City \& County Jail. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Patients receiving Sof/Vel (Epclusa) and Navigation services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2017to 4 Jun 2018
- 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
- a detectable HCV viral load
- no medical contraindications to treatment, including limited life expectancy of less than 12-months due to non-liver related comorbid conditions or renal failure with creatinine clearance of < 30 mL/min.
- Must start HCV treatment while detained
- HIV positive or negative status
- HBV positive or negative status
- treatment-naïve or experienced
- with or without cirrhosis
Who cannot join
- a limited life expectancy of less than 12-months due to non-liver related comorbid conditions
- current or history of decompensated cirrhosis, defined as presence of ascites, hepatic encephalopathy, or variceal bleeding within the past 6 months.
- severe renal impairment defined as creatinine clearance of < 30 mL/min or end stage renal disease (ESRD) on hemodialysis
- pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Jail Health Services
San Francisco, California, 94103
About this study
Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess the feasibility of a HCV treatment program in the San Francisco City \& County Jail. The Jail Health Services will treat 100 patients using the FDA approved combination treatment, sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during incarceration and after their release (if applicable).
Read the detailed description
Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will be conducted in the San Francisco County Jails. Jail settings can provide an optimal opportunity to screen for HCV, initiate curative treatment, and link patients to community HCV providers to complete their treatment. This demonstration project will be funded by the Gilead's Investigator Sponsored Research. The purpose is to assess the feasibility of treating inmates with the FDA approved combination oral treatment, sofosbuvir/velpatasvir, Epclusa®. The San Francisco Department of Public Health's Jail Health Services will treat 100 patients. Intensive patient navigators will be an essential component for treatment to ensure medication adherence and achieve SVR for those who are discharged from jail prior to HCV treatment completion. Navigators will provide short-term case management services by linking patients to medical and social support services. This demonstration project will be facilitated by the Jail Health Services' HIV \& Integrated Services (formerly Forensic AIDS Project).
- Conditions
- Hepatitis C, Chronic
- Being tested
- Patients receiving Sof/Vel (Epclusa) and Navigation services
- Keywords
- Hepatitis C, Chronic, Jail, Patient Navigation, Incarcerated Population, HCV, Sofosbuvir/Velpatasvir, Hepatitis C
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients receiving Sof/Vel (Epclusa) and Navigation servicesDrug
Implementing HCV treatment in the jails using FDA-approved medications and continuing there treatment in the community if they are released during their treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| Navigation services with sof/vel therapy | Other | This a single group demonstration project in which, patients are treated with the FDA-approved drug, Sofosbuvir/Velpatasvir (Epclusa). If a patients is released during their treatment regimen, they will receive patient navigation services to continue their care and treatment in the community. Receives: Drug: Patients receiving Sof/Vel (Epclusa) and Navigation services |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12 of 70% or greater
The primary objective is to implement a feasible HCV treatment program in an urban jail setting, City \& County of San Francisco, over a 12 month period, with demonstration of a SVR12 of 70% or greater among inmates who initiates HCV treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start5 Mar 2017
- Primary completion4 Mar 2018 (estimated)
- Study completion4 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Francisco Department of Public Health
- Sponsor type
- Other government
- Collaborators
- University of California, San Francisco, San Francisco Study Center, Gilead Sciences
- Responsible party
- Principal investigator, Lisa Pratt, MD, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018353
- Sponsor's protocol ID
- IN-US-337-1941
- Acronym
- CHIP
- Status last verified
- May 2017
- First submitted
- 10 Jan 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other outside researchers who are not participating in this pilot demonstration project.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curing HCV in Incarcerated Patients
- ClinicalTrials.gov ID
- NCT03018353
- Acronym / sponsor ID
- CHIP / IN-US-337-1941
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C, Chronic, Jail, Patient Navigation, Incarcerated Population, HCV, Sofosbuvir/Velpatasvir, Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- San Francisco Department of Public HealthOther government
- Collaborators
- University of California, San Francisco, San Francisco Study Center, Gilead Sciences
- Study start
- 5 Mar 2017 (actual)
- Primary completion
- 4 Mar 2018 (estimated)
- Study completion
- 4 Jun 2018 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- 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.
Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess the feasibility of a HCV treatment program in the San Francisco City \& County Jail. The Jail Health Services will treat 100 patients using the FDA approved combination treatment, sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during incarceration and after their release (if applicable).
Detailed description
Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will be conducted in the San Francisco County Jails. Jail settings can provide an optimal opportunity to screen for HCV, initiate curative treatment, and link patients to community HCV providers to complete their treatment. This demonstration project will be funded by the Gilead's Investigator Sponsored Research. The purpose is to assess the feasibility of treating inmates with the FDA approved combination oral treatment, sofosbuvir/velpatasvir, Epclusa®. The San Francisco Department of Public Health's Jail Health Services will treat 100 patients. Intensive patient navigators will be an essential component for treatment to ensure medication adherence and achieve SVR for those who are discharged from jail prior to HCV treatment completion. Navigators will provide short-term case management services by linking patients to medical and social support services. This demonstration project will be facilitated by the Jail Health Services' HIV \& Integrated Services (formerly Forensic AIDS Project).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Navigation services with sof/vel therapy | Other | Drug: Patients receiving Sof/Vel (Epclusa) and Navigation servicesThis a single group demonstration project in which, patients are treated with the FDA-approved drug, Sofosbuvir/Velpatasvir (Epclusa). If a patients is released during their treatment regimen, they will receive patient navigation services to continue their care and treatment in the community. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- a detectable HCV viral load
- no medical contraindications to treatment, including limited life expectancy of less than 12-months due to non-liver related comorbid conditions or renal failure with creatinine clearance of < 30 mL/min.
- Must start HCV treatment while detained
- HIV positive or negative status
- HBV positive or negative status
Key exclusion criteria (4 listed)
- a limited life expectancy of less than 12-months due to non-liver related comorbid conditions
- current or history of decompensated cirrhosis, defined as presence of ascites, hepatic encephalopathy, or variceal bleeding within the past 6 months.
- severe renal impairment defined as creatinine clearance of < 30 mL/min or end stage renal disease (ESRD) on hemodialysis
- pregnant
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 |
|---|---|---|
| Patients receiving Sof/Vel (Epclusa) and Navigation servicesImplementing HCV treatment in the jails using FDA-approved medications and continuing there treatment in the community if they are released during their treatment regimen. | Drug | Navigation services with sof/vel therapy |
Primary outcome
SVR12 of 70% or greater
Time frame: 12 months
The primary objective is to implement a feasible HCV treatment program in an urban jail setting, City \& County of San Francisco, over a 12 month period, with demonstration of a SVR12 of 70% or greater among inmates who initiates HCV treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Individual participant dataSharing planned: No. No IPD will be shared with other outside researchers who are not participating in this pilot demonstration project.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Patients receiving Sof/Vel (Epclusa) and Navigation services in people with Hepatitis C, Chronic, run by San Francisco Department of Public Health 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Jun 2017. 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?
Results are not available in the source record.
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?
SVR12 of 70% or greater (time frame: 12 months). 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 1 Jun 2017.