Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-30 @ 8:09 AM
Study NCT ID:
NCT02768961
Status:
COMPLETED
Last Update Posted:
2017-05-18
First Post:
2016-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'C000595958', 'term': 'ledipasvir, sofosbuvir drug combination'}, {'id': 'C586541', 'term': 'ledipasvir'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-17', 'studyFirstSubmitDate': '2016-05-02', 'studyFirstSubmitQcDate': '2016-05-09', 'lastUpdatePostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of chronic hepatitis C', 'timeFrame': '12 months after the beginning of the study.', 'description': 'Percentage of viremic hepatitis C patients with respect to the whole inmate population'}, {'measure': 'Percentage of Participants with Sustained Virological Response', 'timeFrame': '12 weeks after the end of treatment', 'description': 'Percentage of Participants with Sustained Virological Response (undetectable viral load) at this point'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '4 weeks after the start of treatment', 'description': 'Presence and type of adverse events at this point.'}, {'measure': 'Adverse events', 'timeFrame': '8 weeks after the start of treatment', 'description': 'Presence and type of adverse events at this point.'}, {'measure': 'Adverse events', 'timeFrame': '12 weeks after the start of treatment', 'description': 'Presence and type of adverse events at this point.'}, {'measure': 'Adverse events', 'timeFrame': '24 weeks after the start of treatment', 'description': 'Presence and type of adverse events at this point.'}, {'measure': 'Percentage of Participants with Sustained Virological Response', 'timeFrame': '4 weeks after the end of treatment', 'description': 'Percentage of Participants with Sustained Virological Response (undetectable viral load) at this point'}, {'measure': 'HCV seroprevalence', 'timeFrame': 'baseline', 'description': 'Presence of anti-HCV at baseline'}, {'measure': 'HBV seroprevalence', 'timeFrame': 'baseline', 'description': 'Presence of HBsAg seropositivity'}, {'measure': 'HIV seroprevalence', 'timeFrame': 'baseline', 'description': 'Presence of anti-HIV at baseline'}, {'measure': 'Chronic HCV infection prevalence', 'timeFrame': 'baseline', 'description': 'Detectable HCV RNA viral load at baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sofosbuvir', 'ledipasvir', 'ribavirin', 'prisoner', 'hepatitis c', 'prevalence', 'hepatitis b'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '25911336', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22505121', 'type': 'BACKGROUND', 'citation': 'Rice 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.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are:\n\n1. 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.\n2. To perform an adequate characterization of patients and the characteristics of HCV infection in this population.\n3. To evaluate the effectiveness and security in the prison population of an interferon-free antiviral regimen.\n4. 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.', 'detailedDescription': 'Background:\n\nInfections 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.\n\nFinally, a program of this nature is intended as a pilot experience that could be extended to other prison communities at national and European level.\n\nEndpoints\n\n1. \\- To estimate the prevalence of HBV, HCV and HIV in the inmate population of El Dueso.\n2. \\- 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.\n3. \\- 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.\n4. \\- To evaluate the rates of persistent infection, reinfection and super-infection as defined.\n\nProjected Study Design\n\nThe 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.\n\nIn 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.\n\nPatients and Methods:\n\nPatients:\n\n1. \\- Epidemiological transversal phase: 435 subjects (the whole inmate population) will be included.\n2. \\- 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.\n\nEndpoints:\n\nPrimary endpoint: Sustained Virological Response (SVR) at 12 weeks after the end of treatment.\n\nSecondary outcomes: SVR at 4 weeks, Safety issues, Quality of life, Serum prevalence of chronic HCV, HBV infection; re-infection/superinfection rates; cost-effectiveness\n\nVariables:\n\nVariables: 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\n\nProjected Number of Sites (if additional sites, please specify)\n\n1 (El Dueso Penitentiary Centre)\n\nParticipating Countries\n\n1 (Spain)\n\nAnticipated First Patient In\n\n2-1-2016\n\nProjected Duration of Enrollment\n\n1 month for the prevalent inmate population. The entry of subjets (new inmates) will be open throughout the study\n\nProjected Duration of Treatment\n\n6 month (8-24 weeks according to patient and virological characteristics).\n\nStudy Duration\n\n31 months (1 month enrollment + 6 months of treatment + 24 months observation and final evaluation of reinfections)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Epidemiology study: All inmates at the El Dueso Penitentiary Centre including new admissions within the study period.\n* Interventional study: All HCV infected patients with detectable viral load (HCV RNA)\n* Informed consent signature\n\nExclusion Criteria:\n\n* Not informed consent signature.\n* Pregnant or breastfeeding women\n* Hypersensitivity or any temporary or permanent absolute contraindication to either drug that should be prescribed according to clinical and virological characteristics of the patient.'}, 'identificationModule': {'nctId': 'NCT02768961', 'acronym': 'JAILFREE-C', 'briefTitle': 'Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C)', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Marqués de Valdecilla'}, 'officialTitle': 'Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria. JAILFREE-C', 'orgStudyIdInfo': {'id': 'JCG-SOFLDP-2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active treatment', 'description': '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)\n\n(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.', 'interventionNames': ['Drug: sofosbuvir', 'Drug: ledipasvir']}], 'interventions': [{'name': 'sofosbuvir', 'type': 'DRUG', 'otherNames': ['Harvoni'], 'description': 'Subjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc.\n\nSofosbuvir will be used in association with ledipasvir. In some cases, ribavirin can be added to this combination according to current guidelines', 'armGroupLabels': ['Active treatment']}, {'name': 'ledipasvir', 'type': 'DRUG', 'otherNames': ['Harvoni'], 'description': 'Subjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc.\n\nLedipasvir will be used in association with sofosbuvir. In some cases, ribavirin can be added to this combination according to current guidelines', 'armGroupLabels': ['Active treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39740', 'city': 'Santoña', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Penitentiary "El Dueso". Cantabria. Spain', 'geoPoint': {'lat': 43.44386, 'lon': -3.45757}}], 'overallOfficials': [{'name': 'Javier Crespo García, MDPhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla'}, {'name': 'Carmen Cobo Pelayo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministerio del Interior. Secretaría General de Instituciones Penitenciarias'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Marqués de Valdecilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}