Hepatitis CPhase 4JAILFREE-CNCT02768961
Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C)
A Phase 4 study testing sofosbuvir and ledipasvir in people with Hepatitis C, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
Trial summary
The objectives of this study are: 1. To perform a systematic screening and evaluation of the prevalence of infection by hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV) in the prison population. 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- sofosbuvir and ledipasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2016to 10 May 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Epidemiology study: All inmates at the El Dueso Penitentiary Centre including new admissions within the study period.
- Interventional study: All HCV infected patients with detectable viral load (HCV RNA)
- Informed consent signature
Who cannot join
- Not informed consent signature.
- Pregnant or breastfeeding women
- Hypersensitivity or any temporary or permanent absolute contraindication to either drug that should be prescribed according to clinical and virological characteristics of the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria. JAILFREE-C
The objectives of this study are:
- To perform a systematic screening and evaluation of the prevalence of infection by hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV) in the prison population.
- To perform an adequate characterization of patients and the characteristics of HCV infection in this population.
- To evaluate the effectiveness and security in the prison population of an interferon-free antiviral regimen.
- To evaluate the impact of a strategy of systematic HCV treatment on the rates of persistent infection, reinfection and super-infection in a prison population, in the short, medium and long term.
Read the detailed description
Background:
Infections caused by hepatitis B, C and HIV viruses represent a serious health problem. The inmate population represents a reservoir with high prevalence of these kind of infections. The completion of a secondary prevention through early detection of infections in early stages, and tertiary prevention by treatment of diagnosed cases, constitutes one of the pillars of the approach to these diseases. This strategy is even more valuable in the inmate population because it can help eliminate a source of spread of these diseases in addition to relieving the burden of disease in this population. In this regard, one of the mandates of the recently adopted National Strategy Plan for the Hepatitis C in Spain emphasizes these strategies.
Finally, a program of this nature is intended as a pilot experience that could be extended to other prison communities at national and European level.
Endpoints
- - To estimate the prevalence of HBV, HCV and HIV in the inmate population of El Dueso.
- - To perform a systematic treatment of the inmate population against HCV infection. The treatment will be directed to both, the prevalent population and the new prisoners who enter the prison. The other detected infections will be also treated accordingly.
- - To carry out a descriptive evaluation of the efficacy and safety of an interferon-free regimen against the HCV infection in this population. This regimen will be mainly based on Sofosbuvir and ledipasvir (± RBV) according to the current clinical practice adopted in the National Strategy Plan for the Hepatitis C.
- - To evaluate the rates of persistent infection, reinfection and super-infection as defined.
Projected Study Design
The present study is divided in two parts. A transversal and observational one of epidemiological basis aimed to determine the prevalence of viral infections by hepatitis B and C viruses and also by HIV in the inmate population.
In a second prospective phase of follow-up, a systematic treatment of the infected cohort will be carried out in accordance with the current clinical practice adopted in the National Strategy Plan for the Hepatitis C. Data on efficacy, safety and quality of life will be collected throughout the study. Finally, an evaluation of the rates of persistent infection, reinfection and super-infection will be also recorded. Treatment of new admissions throughout the study periods is also contemplated.
Patients and Methods:
Patients:
- - Epidemiological transversal phase: 435 subjects (the whole inmate population) will be included.
- - Prospective observational phase: 120 infected patients (taking into account a reported chronic HCV infection prevalence of 20% in the inmate population -data from the latest National Strategic Plan for addressing hepatitis C in the National Health Service "NHS" 2015-) and that it is intended to treat newly infected inmate who enter in prison during the two years of study.
Endpoints:
Primary endpoint: Sustained Virological Response (SVR) at 12 weeks after the end of treatment.
Secondary outcomes: SVR at 4 weeks, Safety issues, Quality of life, Serum prevalence of chronic HCV, HBV infection; re-infection/superinfection rates; cost-effectiveness
Variables:
Variables: HCV status by ELISA; Viral load (PCR) HCV IU / ml (primary), treatment type and duration, serological status of HBV infection; liver stiffness through Fibroscan. QoL variables, ultrasonographic variables. phylogenetic analysis of HCV genome in cases of non-response. costs
Projected Number of Sites (if additional sites, please specify)
1 (El Dueso Penitentiary Centre)
Participating Countries
1 (Spain)
Anticipated First Patient In
2-1-2016
Projected Duration of Enrollment
1 month for the prevalent inmate population. The entry of subjets (new inmates) will be open throughout the study
Projected Duration of Treatment
6 month (8-24 weeks according to patient and virological characteristics).
Study Duration
31 months (1 month enrollment + 6 months of treatment + 24 months observation and final evaluation of reinfections)
- Conditions
- Hepatitis C
- Being tested
- sofosbuvir, ledipasvir
- Keywords
- sofosbuvir, ledipasvir, ribavirin, prisoner, hepatitis c, prevalence, hepatitis b
- Medical subject headings
- Hepatitis C, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofosbuvirDrug
Also called Harvoni
Subjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc.
Sofosbuvir will be used in association with ledipasvir. In some cases, ribavirin can be added to this combination according to current guidelines
ledipasvirDrug
Also called Harvoni
Subjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc.
Ledipasvir will be used in association with sofosbuvir. In some cases, ribavirin can be added to this combination according to current guidelines
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | All HCV chronic infected patients will be treated with oral anti-HCV regimens containing sofosbuvir, ledipasvir (associated or not to ribavirin) according to clinical practice as indicated into the current guidelines (1)
(1)European Association for Study of Liver (EASL). EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. PubMed PMID: 25911336. Receives: Drug: sofosbuvir; Drug: ledipasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of chronic hepatitis C
Percentage of viremic hepatitis C patients with respect to the whole inmate population
Measured: 12 months after the beginning of the study.
Percentage of Participants with Sustained Virological Response
Percentage of Participants with Sustained Virological Response (undetectable viral load) at this point
Measured: 12 weeks after the end of treatment
Secondary outcomes (9)
Adverse events
Presence and type of adverse events at this point.
Measured: 4 weeks after the start of treatment
Adverse events
Presence and type of adverse events at this point.
Measured: 8 weeks after the start of treatment
Adverse events
Presence and type of adverse events at this point.
Measured: 12 weeks after the start of treatment
Adverse events
Presence and type of adverse events at this point.
Measured: 24 weeks after the start of treatment
Percentage of Participants with Sustained Virological Response
Percentage of Participants with Sustained Virological Response (undetectable viral load) at this point
Measured: 4 weeks after the end of treatment
HCV seroprevalence
Presence of anti-HCV at baseline
Measured: baseline
HBV seroprevalence
Presence of HBsAg seropositivity
Measured: baseline
HIV seroprevalence
Presence of anti-HIV at baseline
Measured: baseline
Chronic HCV infection prevalence
Detectable HCV RNA viral load at baseline
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start10 May 2016
- Primary completion10 May 2017
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Crespo García, MDPhD, Study director, Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de ValdecillaCarmen Cobo Pelayo, MD, Principal investigator, Ministerio del Interior. Secretaría General de Instituciones Penitenciarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768961
- Sponsor's protocol ID
- JCG-SOFLDP-2015-01
- Acronym
- JAILFREE-C
- Status last verified
- May 2017
- First submitted
- 2 May 2016
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. No abstract available.
PubMed 25911336Rice JP, Burnett D, Tsotsis H, Lindstrom MJ, Cornett DD, Voermans P, Sawyer J, Striker R, Lucey MR. Comparison of hepatitis C virus treatment between incarcerated and community patients. Hepatology. 2012 Oct;56(4):1252-60. doi: 10.1002/hep.25770.
PubMed 22505121
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria. JAILFREE-C
- ClinicalTrials.gov ID
- NCT02768961
- Acronym / sponsor ID
- JAILFREE-C / JCG-SOFLDP-2015-01
- Conditions
- Hepatitis C
- Keywords
- sofosbuvir, ledipasvir, ribavirin, prisoner, hepatitis c, prevalence, hepatitis b
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 11 May 2016 (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.
The objectives of this study are:
- To perform a systematic screening and evaluation of the prevalence of infection by hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV) in the prison population.
- To perform an adequate characterization of patients and the characteristics of HCV infection in this population.
- To evaluate the effectiveness and security in the prison population of an interferon-free antiviral regimen.
- To evaluate the impact of a strategy of systematic HCV treatment on the rates of persistent infection, reinfection and super-infection in a prison population, in the short, medium and long term.
Detailed description
Background:
Infections caused by hepatitis B, C and HIV viruses represent a serious health problem. The inmate population represents a reservoir with high prevalence of these kind of infections. The completion of a secondary prevention through early detection of infections in early stages, and tertiary prevention by treatment of diagnosed cases, constitutes one of the pillars of the approach to these diseases. This strategy is even more valuable in the inmate population because it can help eliminate a source of spread of these diseases in addition to relieving the burden of disease in this population. In this regard, one of the mandates of the recently adopted National Strategy Plan for the Hepatitis C in Spain emphasizes these strategies.
Finally, a program of this nature is intended as a pilot experience that could be extended to other prison communities at national and European level.
Endpoints
- - To estimate the prevalence of HBV, HCV and HIV in the inmate population of El Dueso.
- - To perform a systematic treatment of the inmate population against HCV infection. The treatment will be directed to both, the prevalent population and the new prisoners who enter the prison. The other detected infections will be also treated accordingly.
- - To carry out a descriptive evaluation of the efficacy and safety of an interferon-free regimen against the HCV infection in this population. This regimen will be mainly based on Sofosbuvir and ledipasvir (± RBV) according to the current clinical practice adopted in the National Strategy Plan for the Hepatitis C.
- - To evaluate the rates of persistent infection, reinfection and super-infection as defined.
Projected Study Design
The present study is divided in two parts. A transversal and observational one of epidemiological basis aimed to determine the prevalence of viral infections by hepatitis B and C viruses and also by HIV in the inmate population.
In a second prospective phase of follow-up, a systematic treatment of the infected cohort will be carried out in accordance with the current clinical practice adopted in the National Strategy Plan for the Hepatitis C. Data on efficacy, safety and quality of life will be collected throughout the study. Finally, an evaluation of the rates of persistent infection, reinfection and super-infection will be also recorded. Treatment of new admissions throughout the study periods is also contemplated.
Patients and Methods:
Patients:
- - Epidemiological transversal phase: 435 subjects (the whole inmate population) will be included.
- - Prospective observational phase: 120 infected patients (taking into account a reported chronic HCV infection prevalence of 20% in the inmate population -data from the latest National Strategic Plan for addressing hepatitis C in the National Health Service "NHS" 2015-) and that it is intended to treat newly infected inmate who enter in prison during the two years of study.
Endpoints:
Primary endpoint: Sustained Virological Response (SVR) at 12 weeks after the end of treatment.
Secondary outcomes: SVR at 4 weeks, Safety issues, Quality of life, Serum prevalence of chronic HCV, HBV infection; re-infection/superinfection rates; cost-effectiveness
Variables:
Variables: HCV status by ELISA; Viral load (PCR) HCV IU / ml (primary), treatment type and duration, serological status of HBV infection; liver stiffness through Fibroscan. QoL variables, ultrasonographic variables. phylogenetic analysis of HCV genome in cases of non-response. costs
Projected Number of Sites (if additional sites, please specify)
1 (El Dueso Penitentiary Centre)
Participating Countries
1 (Spain)
Anticipated First Patient In
2-1-2016
Projected Duration of Enrollment
1 month for the prevalent inmate population. The entry of subjets (new inmates) will be open throughout the study
Projected Duration of Treatment
6 month (8-24 weeks according to patient and virological characteristics).
Study Duration
31 months (1 month enrollment + 6 months of treatment + 24 months observation and final evaluation of reinfections)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Drug: sofosbuvir, Drug: ledipasvirAll HCV chronic infected patients will be treated with oral anti-HCV regimens containing sofosbuvir, ledipasvir (associated or not to ribavirin) according to clinical practice as indicated into the current guidelines (1) (1)European Association for Study of Liver (EASL). EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. PubMed PMID: 25911336. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Epidemiology study: All inmates at the El Dueso Penitentiary Centre including new admissions within the study period.
- Interventional study: All HCV infected patients with detectable viral load (HCV RNA)
- Informed consent signature
Key exclusion criteria (3 listed)
- Not informed consent signature.
- Pregnant or breastfeeding women
- Hypersensitivity or any temporary or permanent absolute contraindication to either drug that should be prescribed according to clinical and virological characteristics of the patient.
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 |
|---|---|---|
| sofosbuvirAlso: HarvoniSubjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc. Sofosbuvir will be used in association with ledipasvir. In some cases, ribavirin can be added to this combination according to current guidelines | Drug | Active treatment |
| ledipasvirAlso: HarvoniSubjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc. Ledipasvir will be used in association with sofosbuvir. In some cases, ribavirin can be added to this combination according to current guidelines | Drug | Active treatment |
Primary outcome
Prevalence of chronic hepatitis C
Time frame: 12 months after the beginning of the study.
Percentage of viremic hepatitis C patients with respect to the whole inmate population
Percentage of Participants with Sustained Virological Response
Time frame: 12 weeks after the end of treatment
Percentage of Participants with Sustained Virological Response (undetectable viral load) at this point
9 secondary outcomes
Adverse events
Time frame: 4 weeks after the start of treatment
Adverse events
Time frame: 8 weeks after the start of treatment
Adverse events
Time frame: 12 weeks after the start of treatment
Adverse events
Time frame: 24 weeks after the start of treatment
Percentage of Participants with Sustained Virological Response
Time frame: 4 weeks after the end of treatment
HCV seroprevalence
Time frame: baseline
HBV seroprevalence
Time frame: baseline
HIV seroprevalence
Time frame: baseline
Chronic HCV infection prevalence
Time frame: baseline
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 18 May 2017.
- Background: PubMed 25911336European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. No abstract available.
- Background: PubMed 22505121Rice JP, Burnett D, Tsotsis H, Lindstrom MJ, Cornett DD, Voermans P, Sawyer J, Striker R, Lucey MR. Comparison of hepatitis C virus treatment between incarcerated and community patients. Hepatology. 2012 Oct;56(4):1252-60. doi: 10.1002/hep.25770.
- 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.
Javier Crespo García, MDPhD study director
Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla
Carmen Cobo Pelayo, MD principal investigator
Ministerio del Interior. Secretaría General de Instituciones Penitenciarias
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 sofosbuvir and ledipasvir in people with Hepatitis C, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
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 3 inclusion and 3 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 18 May 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 Spain. 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 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?
Prevalence of chronic hepatitis C (time frame: 12 months after the beginning of the study.). 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?
On the ClinicalTrials.gov record for NCT02768961, which also lists 2 linked publications.
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 18 May 2017.