[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatitis-c\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatitis-c":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,46,75,99,122,153,177,201,227,252,272,296,319,348,379,409,432,463,485,509,534,553,576,594,625],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100596043","phase-1-study-of-the-pharmacokinetics-and-safety-of-glecaprevirpibrentasvir-initiated-in-pregnancy-in-women-with-hepatitis-c-with-and-without-hiv-100596043",false,"NCT07040319","Study of the Pharmacokinetics and Safety of Glecaprevir\u002FPibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV","Phase I\u002FII Study of the Pharmacokinetics and Safety of Glecaprevir\u002FPibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV","Inclusion Criteria:\n\n* Of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with institutional review board\u002Fethics committee (IRB\u002FEC) policies and procedures\n* Willing and able to provide written informed consent for their own and their infant's study participation\n* At entry, 16-45 years of age (inclusive)\n* At entry, gestational age of 14-32 weeks, defined as greater than 13 weeks plus six days and less than or equal to 32 completed weeks gestation, as determined by the site investigator based on best obstetric estimate\n* At screening and at study entry, no evidence of multiple gestation, fetal anomalies, or intrauterine fetal growth restriction, as determined by the site investigator based on ultrasound\n* At screening, detectable HCV RNA test result based on testing of a specimen collected within 30 days prior to entry\n* At screening, negative test results for hepatitis B surface antigen based on testing of a specimen collected within 30 days prior to entry\n* At screening (i.e., from specimens collected within 30 days prior to entry), has normal, grade 1, grade 2, or grade 3 results for the following\n\n  * Aspartate aminotransferase (AST) (\\\u003C10.0 x ULN)\n  * Alanine aminotransferase (ALT) (\\\u003C10.0 x ULN)\n* At screening (i.e., from specimens collected within 30 days prior to entry), has normal, grade 1, or grade 2 results for the following\n\n  * Hemoglobin (≥8.5 g\u002FdL)\n  * Creatinine (≤1.8 x ULN)\n* At screening (i.e., from specimens collected within 30 days prior to entry), has normal or grade 1 results for the following\n\n  * International normalized ratio (INR) (\\\u003C1.5 x ULN)\n  * Platelet count (≥100,000 cells\u002Fmm3)\n  * Total bilirubin (\\\u003C1.6 x ULN)\n* HIV status determined based on testing meeting the requirements specified in protocol\n* For pregnant participants living with HIV: has a suppressed HIV viral load (HIV-1 RNA below the limit of quantification of the assay) on an ARV regimen for at least 30 consecutive days prior to entry that does not include efavirenz, etravirine, cobicistat, or any protease inhibitor (e.g., atazanavir, darunavir, lopinavir, ritonavir), as determined by the site investigator based on available medical records\n* At entry, expects to remain in the geographic area of the study site during pregnancy and for 10 weeks postpartum (or for 20 weeks post-entry, depending on gestational age at entry), as determined by the site investigator based on pregnant participant report\n\nExclusion Criteria:\n\n* Any previous treatment for hepatitis C, including HCV DAAs or interferon-based treatment\n* High risk of preterm delivery, defined as either of the following:\n\n  * History of spontaneous preterm delivery at less than 34 weeks, as determined by the site investigator based on pregnant participant report and available medical records, or\n  * Shortened cervix less than 20 mm if noted on ultrasound during the current pregnancy, as determined by the site investigator based on available medical records\n* Receipt of any prohibited medication, within 14 days prior to entry, as determined by the site investigator based on pregnant participant report and available medical records\n* Any of the following liver-related conditions:\n\n  * Clinical diagnosis of acute hepatitis not otherwise attributable to hepatitis C with AST or ALT ≥2.5 x ULN\n  * Evidence of decompensated cirrhosis including history of or present variceal hemorrhage, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatocellular carcinoma, hepatorenal syndrome, or hepatopulmonary syndrome\n* Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives","FEMALE","16 Years","45 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a Phase I\u002FII, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir\u002Fpibrentasvir (GLE\u002FPIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection (acute or chronic) with or without HIV and to evaluate safety for their infants through 10 weeks postpartum.",[28],"Hepatitis C",[30,28,31,32],"HIV","Pregnancy","Glecaprevir\u002FPibrentasvir","RECRUITING","2026-06-29",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2026-06-25",{"date":41,"type":21},"2027-10-30",{"name":43,"class":44},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",10,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":4,"leadSponsor":72,"locationsCount":74},"100054882","evaluation-of-patients-with-liver-disease-100054882","NCT00001971","Evaluation of Patients With Liver Disease","* INCLUSION CRITERIA:\n\nAffected Subjects\n\nIn order to be eligible to participate in this study, an affected participant must meet all of the following criteria:\n\n1. \\>=2 years of age.\n2. Meets one of the following:\n\n   1. Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), OR\n   2. At risk for acute or chronic liver disease\n\nHealthy Volunteers\n\nIn order to be eligible to participate in this study, a healthy volunteer must meet all of the following criteria:\n\n1. \\>= 18 years of age.\n2. In good general health as evidenced by medical history\n\nEXCLUSION CRITERIA:\n\nAffected Participants\n\nAn affected participant who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. History of significant medical illnesses that might interfere with prolonged follow up evaluation\n\nHealthy Volunteers\n\nA healthy volunteer who meets any of the following criteria will be excluded from participation in this study:\n\n1. Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases\n2. Taking any regular medications or supplements (with the exception of regular multivitamins and\u002For oral contraceptives)\n3. Average alcohol consumption \\> 1 drink\u002Fday in past 6 months, per self-report\n4. History of liver disease (with the exception of neonatal jaundice)\n5. History of severe illness, infection or major surgery in the past year\n6. History of cancer (with the exception of basal cell carcinoma resected \\> 1 year prior to enrollment)\n7. BMI \\\u003C 18 or BMI \\>25\n8. Hemoglobin \\\u003C 11 (women) or hemoglobin \\\u003C 12 (men)\n9. ALT \\>35 (men) or ALT \\>25 (women)\n10. Alkaline Phosphatase \\>= 150\n11. Bilirubin \\>2 g\u002FdL\n12. HIV positive, Anti-HCV positive, HBsAg positive or Anti-HBc positive\n13. Pregnancy\n14. Inability to provide informed consent",true,"ALL","2 Years","100 Years",{"count":57,"type":21},8050,"OBSERVATIONAL","The proposed study aims to evaluate, investigate, and follow-up patients suffering from acute and chronic liver disease. The study will focus on understanding diseases affecting the liver.\n\nPatients participating in the study will first undergo a routine check-up as an outpatient. They will be asked to provide blood and urine samples for laboratory testing and will undergo an ultrasound of the liver. Ultrasound examinations use sound waves to determine the size and texture of the liver. After the initial visit subjects will be requested to follow-up once a year at the outpatient department for a similar check-up.\n\nAdditional tests may be requested throughout the study to provide information for other research studies and individual consent will be requested. These tests may include liver biopsies, skin biopsies, and \u002F or specialized blood, plasma, and lymphocyte examinations.\n\nSubjects that qualify for medications presently being studied may be offered the opportunity to benefit from experimental therapy.",[61,28,62,63],"Hepatitis D","Hepatitis B","Liver Disease",[62,28,61,65,66,63],"Chronic Hepatitis","Natural History","2026-06-27",{"date":69,"type":37},"2026-06-30",{"date":71,"type":37},"1992-05-27",{"name":73,"class":44},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100544329","feasibility-and-acceptability-of-hcv-treatment-in-pregnancy-100544329","NCT06367465","Feasibility and Acceptability of HCV Treatment in Pregnancy","Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy","Inclusion Criteria:\n\n* Female patients ≥ 18 years old, pregnant at the time of study intake, diagnosed with hepatitis c virus infection and a history of past or current drug use.\n\nExclusion Criteria:\n\n\\-","18 Years",{"count":84,"type":21},50,"Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug use\n\nParticipant Duration: Approximately 1 year.\n\nAims:\n\nAim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs.\n\nAim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy.",[28,87],"Pregnancy Complications","2026-06-05",{"date":90,"type":37},"2026-06-09",{"date":92,"type":37},"2024-02-01",{"date":94,"type":21},"2026-12-28",{"name":96,"class":97},"Washington University School of Medicine","OTHER",2,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":74},"100182092","proteogenomic-monitoring-and-assessment-of-liver-transplant-recipients-100182092","NCT01644903","Proteogenomic Monitoring and Assessment of Liver Transplant Recipients","\"Mini-Liver\"","Inclusion Criteria:\n\n1. Male and female recipients of all races, ≥18 years of age.\n2. Patients undergoing primary or subsequent living or deceased donor liver transplantation.\n3. Subject and\u002For guardian must be able to provide informed consent.\n4. Subject and\u002For guardian must be able to comply with the study protocol.\n\nExclusion Criteria:\n\n1\\. Inability or unwillingness of a participant and\u002For guardian to provide informed consent.",{"count":107,"type":21},1000,"This study is being done to test blood, urine and tissue samples to see if this can help decide if CKD (Chronic Kidney Disease), AR (Acute Rejection) and HCV (Hepatitis C Virus) can be identified in its early stages. CKD damage to the kidneys, AR and HCV all lower the body's ability to function properly. Early detection of these conditions could assist with successful treatment and possibly lead to less repeat organ transplants.",[110,28,111,112],"Liver Transplant","Chronic Kidney Disease","Acute Rejection","2026-05-20",{"date":115,"type":37},"2026-05-22",{"date":117,"type":4},"2010-04",{"date":119,"type":21},"2031-12",{"name":121,"class":97},"Northwestern University",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":52,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":152},"100338330","ethos-engage-enhancing-treatment-of-hepatitis-c-in-opioid-substitution-settings-100338330","NCT03685045","ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings","Enhancing Treatment of Hepatitis C in Opioid Substitution Settings II (ETHOS II): A Partnership Project to Enhance Hepatitis C Care in Drug and Alcohol Clinics","ETHOS II","Inclusion Criteria:\n\n* Participant has voluntarily signed the informed consent form;\n* 18 years of age or older;\n* History of injecting drug use\\*;\n* Recent injecting drug use (previous six months) or currently receiving OST\\*.\n\n  * These criteria will not apply for recruitment from residential rehabilitation centres\n\nExclusion Criteria:\n\n* Nil",{"count":131,"type":21},6000,[133],"NA","The overall goals of the ETHOS II Project are to enhance hepatitis C virus (HCV) care in drug treatment clinics and needle and syringe programs (NSPs) in New South Wales and Australia, and to develop a translational framework for subsequent establishment of HCV screening and treatment programs in drug treatment clinics and NSPs across NSW and nationally.",[28],[137,138,139,140,141],"hepatitis c","opioid substitution settings","OST","people who inject drugs","direct-acting antiviral treatment","2026-05-11",{"date":144,"type":37},"2026-05-14",{"date":146,"type":37},"2018-05-28",{"date":148,"type":21},"2028-12-31",{"name":150,"class":151},"Kirby Institute","OTHER_GOV",32,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":52,"sex":53,"minAge":82,"maxAge":18,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100611184","phase-1-a-phase-1-clinical-trial-of-adjuvanted-protein-based-hcv-vaccine-candidates-hcv-vaccine-trial-100611184","NCT07237282","A Phase 1 Clinical Trial of Adjuvanted Protein-based HCV Vaccine Candidates (HCV Vaccine Trial)","Inclusion Criteria:\n\n1. Able to understand the purpose and the procedures involved in this study and sign the informed consent form;\n2. Non-pregnant individuals, 18-45 years of age inclusive;\n3. Individuals must agree not to become pregnant during the trial. If they are capable of pregnancy and sexually active, they must use an effective method of birth control;\n4. Non-smoker and in good general health, as determined by medical screening evaluation, performed by PI, or delegated sub-investigator no greater than 4 weeks (28 days) before the first dose in the form of medical history, clinical laboratory tests and physical examination;\n5. Agrees to reside in the geographical area for next 12 months and not intending to travel outside of Canada for at least 14 days following each study vaccine administration;\n6. Agree not to participate in any other clinical trial during the trial;\n7. Agree not to donate blood for the duration of the trial;\n8. Agree to restrain from intensive physical exercise i.e., exercise that varies significantly from an everyday exercise routine, 3 days before and after (± 3 days) administration of each dose, including each interim visit for blood sample collection;\n9. Up to date on recommended seasonal vaccines (influenza and COVID-19) at the time of study enrolment.\n\nExclusion Criteria:\n\n1. Presence of Hepatitis C antibody (HCV Ab);\n2. Presence of significant acute infection requiring systemic antibiotic treatment within the 14 days prior to each product administration;\n3. Pregnant or breast feeding (all individuals physiologically capable of pregnancy will have a negative pregnancy test result prior to each study product administered);\n4. Past significant reaction following any previous vaccination;\n5. History of hypersensitivity to any vaccine component;\n6. Presence of acute infectious disease or fever (e.g., sub-lingual temperature 38.5°C) within the five days prior to study product administration;\n7. Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immunodeficiencies), insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, psoriasis, rheumatoid arthritis, asthma, epilepsy or obsessive-compulsive disorder, skin carcinoma excluding non-spreadable skin cancers such as basal cell and squamous cell carcinoma;\n8. Evidence and\u002For any history of leukaemia, lymphoma, or neoplasm;\n9. Presence or suspicion of impaired immune system function. Currently receiving or having within the past three years received immunosuppressive therapy, including systemic steroids, ACTH or inhaled steroids in dosages that are associated with hypothalamic-pituitary-adrenal axis suppression, such as 1mg\u002Fkg\u002Fday of prednisone or its equivalent or chronic use of inhaled high potency corticosteroids \\[budesonide 800 µg per day or fluticasone 750 µg\\];\n10. Received blood, blood products or a parenteral immunoglobulin preparation in the past 12 weeks;\n11. Evidence of bleeding diathesis or any condition that may be associated with a prolonged bleeding time;\n12. Known inherited genetic anomaly (known as cytogenic disorders) e.g., Down's syndrome;\n13. Evidence of any condition that, in the opinion of the clinical investigator, might interfere with the evaluation of the study objectives or pose excessive risks to participants;\n14. Clinically significant abnormal laboratory as assessed by the trial physician.",{"count":160,"type":21},27,[24],"The purpose of this study is to investigate the safety and antibody (germ fighters) response of the experimental (investigational) vaccine against HCV when injected into the arm of healthy adults.",[28],[165],"Vaccine","NOT_YET_RECRUITING","2026-05-04",{"date":169,"type":37},"2026-05-06",{"date":171,"type":21},"2026-08-01",{"date":173,"type":21},"2027-07-01",{"name":175,"class":97},"University of Alberta",3,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":52,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":185,"targetDuration":187,"studyType":58,"phases":4,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100442527","the-australian-hcv-point-of-care-testing-program-100442527","NCT05042544","The Australian HCV Point-of-Care Testing Program","The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection","HCVPOCT","Inclusion Criteria:\n\n1. Provided informed consent.\n2. ≥ 18 years of age.\n3. Have a risk factor for the acquisition of HCV infection (including current or past injecting drug use, previous incarceration, HIV infection, receiving blood products prior to 1990, having a tattoo or piercing in an unregulated environment, a needle-stick injury, or a mother with HCV).\n\n   OR:\n4. Are attending a service caring for people with risk factors for the acquisition of HCV infection (e.g. drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, and homelessness services).\n\nExclusion Criteria:\n\na. Is unable or unwilling to provide informed consent or abide by the requirements of the study.",{"count":186,"type":21},60000,"12 Months","The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). Participants will attend a single visit to have their HCV RNA status tested and complete a self-administered survey. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.",[28],[191],"Hepatitis C Virus","2026-03-26",{"date":194,"type":37},"2026-03-31",{"date":196,"type":37},"2022-02-22",{"date":198,"type":21},"2029-06-30",{"name":150,"class":151},69,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":52,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":74},"100154331","the-1200-patients-project-studying-the-implementation-of-clinical-pharmacogenomic-testing-100154331","NCT01280825","The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing","Inclusion Criteria:\n\n* Receiving ongoing, out-patient care at the University of Chicago Medical Center under the routine care of a physician participating in this trial\n* Life expectancy of at least 3 years\n* Must be 18 years or older\n* Must be taking at least 1 (but not more than 6) prescription medications at the time of enrollment OR be 65 years or older OR be reasonably expected to require the use of a prescription medication within the next 5 years\n* Patients with certain diseases, or likely to receive or be receiving certain drugs, will be targeted particularly for enrollment in order to enrich the study for patients likely to have pharmacogenetically relevant interactions, including, but not limited to:\n\n  * Patients requiring specialized cardiology care\n  * Patients with inflammatory bowel diseases\n  * Patients with systemic autoimmune or inflammatory diseases\n  * Patients requiring long-term oral anticoagulation\n  * Patients with hepatitis C\n  * Patients with non-metastatic cancer\n\nExclusion Criteria:\n\n* Patients with acute or chronic disease which could be reasonably expected to result in the patient's death within the next 3 years.\n* Patients who have undergone, or are being actively considered for, liver or kidney transplantation.\n* Inability to understand and give informed consent to participate.",{"count":208,"type":21},1200,"The purpose of this study is to collect DNA samples from patients undergoing routine care at the University of Chicago. These samples will be tested for differences in genes that may suggest greater risk of side effects or chance of increased benefit from certain medications. The results will be made available to the patient's treating physician and the researchers will track whether or not this information is used in routine health care.",[211,212,213,214,215,216,28,217],"Patients Undergoing Routine Health Care","Heart Diseases","Inflammatory Bowel Diseases","Autoimmune Disease","Inflammatory Disease","Blood Coagulation Disorders","Non-Metastatic Neoplasm","2026-03-02",{"date":220,"type":37},"2026-03-04",{"date":222,"type":37},"2011-01-14",{"date":224,"type":21},"2027-12-14",{"name":226,"class":97},"University of Chicago",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":251},"100469255","screening-for-hepatitis-b-hepatitis-c-and-aids-viruses-using-dried-blood-spot-100469255","NCT05390424","Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot","BUVARD76_27","Inclusion Criteria:\n\n* Former or active intravenous and\u002For nasal drug user\n* Person on opiate substitution therapy\n\nExclusion Criteria:\n\n* Person with known active viral infection(s)",{"count":235,"type":21},500,[133],"The aim of the study is to screen for hepatitis B, hepatitis C and AIDS viruses using a Dried Blood Spot in drug users",[62,28,239],"AIDS",[241],"Dried Blood Spot","2026-02-12",{"date":244,"type":37},"2026-02-17",{"date":246,"type":37},"2022-12-02",{"date":248,"type":21},"2027-01",{"name":250,"class":97},"University Hospital, Rouen",11,{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":52,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":74},"100400373","the-hepatitis-c-transplant-collaborative-100400373","NCT04493385","The Hepatitis C Transplant Collaborative","Nationwide Hepatitis C NAT+ Cardiac Transplant Experience","Inclusion Criteria:\n\n1. Recipient of a proven HCV NAT+ donor heart.\n2. Re-transplant patients will be included.\n\nExclusion Criteria:\n\n1\\. Multi-organ transplantation",{"count":235,"type":21},"In this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing HCV NAT+ donor organs as currently performed are acceptable.",[262,28],"Transplant; Failure, Heart","2026-01-20",{"date":265,"type":37},"2026-01-22",{"date":267,"type":37},"2019-09-16",{"date":269,"type":21},"2030-12",{"name":271,"class":97},"Baylor Research Institute",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":53,"minAge":82,"maxAge":55,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":74},"100375012","use-of-a-patient-centered-electronic-app-to-increase-ed-patients-knowledge-on-hcv-to-improve-the-hcv-care-continuum-100375012","NCT04162938","Use of a Patient-Centered Electronic App to Increase ED Patient's Knowledge on HCV to Improve the HCV Care Continuum","Use of a Patient-Centered Electronic App to Increase Emergency Department Patient's Knowledge on HCV Infection, Disease Progression, and Care to Improve the HCV Care Continuum","Inclusion Criteria:\n\n* Johns Hopkins Hospital ED patient\n* 18 years or older\n* HCV positive without HCV RNA information\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Unable to provide informed consent\n* Altered mental status\n* Incarcerated\n* Critically ill",{"count":280,"type":21},308,[133],"The investigators will conduct a randomized controlled clinical trial study in an urban emergency department in Baltimore to determine the impact of an educational app which is based on Leventhal's Common-Sense Model of Illness Representations framework, on HCV-infected ED patient's hepatitis C virus (HCV) health belief and knowledge as well as the downstream outcomes of the HCV Continuum of Care (linkage to care rate, initiation of HCV antiviral treatment, and sustained virologic response). First, the investigators will develop a blueprinted prototype personalized HCV educational app which will (1) provide individualized liver fibrosis staging information, (2) pre-test HCV knowledge, perception of barriers to HCV care, and motivation to receive HCV care survey, (3) provide personalized HCV knowledge, facilitators and supporting information for HCV care via video clips and information sheets based on the pre-test results, and (4) provide post-test knowledge, perception, and motivation to receive HCV care. Second, the investigators will conduct a series of focus group discussion sessions to fine-tune the HCV educational app. Third, the investigators will enroll ED patients who have anti-HCV (newly diagnosed or previously diagnosed) but without HCV RNA testing information for a pilot randomized controlled clinical trial of the personalized HCV educational app.",[28],[285,286],"HCV Linkage to Care","HCV Education","2025-12-10",{"date":289,"type":37},"2025-12-18",{"date":291,"type":37},"2022-03-24",{"date":293,"type":21},"2026-09",{"name":295,"class":97},"Johns Hopkins University",{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":53,"minAge":82,"maxAge":55,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":74},"100344635","ed-patients-perceptions-and-acceptability-toward-a-novel-poc-hcv-viral-load-testing-100344635","NCT03767231","ED Patient's Perceptions and Acceptability Toward a Novel POC HCV Viral Load Testing","Emergency Department Patient's Perceptions and Acceptability Toward a Novel Point-of-Care Hepatitis C Virus Viral Load Testing","Inclusion Criteria:\n\n* Any Johns Hopkins Emergency Department patient who has HCV antibody positive result but no HCV RNA test result in the chart\n* Able to provide informed consent\n* 18-100 years\n\nExclusion Criteria:\n\n* Patient who has a diagnosis of chronic HCV infection\n* Patient with a non-reactive test result of an HCV Ab screening test\n* Patient with a chief complaint of sexual assault\n* Patients who are otherwise ineligible to consent due to medical condition (e.g., severe illness, altered mental status)\n* Any person who has previously enrolled in this study\n* Any person less than 18 years of age\n* Any person who is incarcerated\n* Any woman who is pregnant\n* Any person who is transgender\n* Any person who is sex worker\n* Any person who is refugee",{"count":304,"type":21},200,[133],"Hepatitis C virus (HCV) infection has become the leading fatal infectious disease in the United States. Approximately 75% of individuals who have been infected with HCV are chronically infected with the virus. Untreated chronic infection will lead to severe sequelae such as cirrhosis and hepatocellular carcinoma. Even though the availability of rapid HCV antibody (HCV Ab) screening assay and highly effective antiviral treatment, most people infected with HCV are not aware of the infection status. This gap mainly comes from the current gold standard confirmatory testing for chronic HCV infection, the Polymerase Chain Reaction (PCR)-based HCV RNA viral load assay which requires an experienced trained laboratory technician to perform relatively complicated PCR assay with a turn-around-time of 1 to 2 days (from provider's order to the test resulting). The investigators' rapid HCV Screening and Linkage to Care program has demonstrated that many patients in the investigators' emergency department (ED) are unaware of patient's chronic HCV infection status due to the barriers to receive the gold standard viral load testing.\n\nRecently, a novel Xpert HCV Viral Load (VL) Finger-stick (FS) \\[Xpert HCV VL FS\\] point-of-care (POC) test (Cepheid) has been developed. In an observational cohort in Australia, HCV RNA was detected in 40% of participants (85 of 210) enrolled at 3 drug treatment clinics and 1 homelessness service. Sensitivity of the Xpert HCV VL FS assay for HCV RNA quantification in samples collected by finger-stick was 100.0% (95% Confidence Interval (CI), 93.9%-100.0%) and specificity was 100.0% (95% CI, 96.6%-100.0%). The Xpert HCV VL FS test can accurately detect active infection from a finger-stick sample in 1 hour allowing single-visit HCV diagnosis.\n\nIn this protocol, the investigators seek to determine the needs and acceptability of a novel POC HCV viral load testing assay among ED HCV Ab positive patients. For this project, the investigators will identify and enroll ED patients with HCV Ab positive but without HCV viral information. The investigators will conduct a randomized study to assign eligible and consented patients to either to POC Testing Group or Standard of Care (SOC) Group. All participants will take a short survey regarding HCV care and treatment. As part of the investigators' ED HCV Screening and Linkage to Care Program, all participants will receive the standard-of-care clinical laboratory-based HCV RNA viral load testing via whole blood (i.e. patient will receive blood drawn). This standard-of-care HCV viral load testing result will be provided to participant when it is available (usually 1-2 days later). Participants in the POC Testing Group will receive the novel POC HCV RNA viral load testing and the result of the novel test will be disclosed to the patients approximately within 2 hours of the testing. Linkage to care information after the ED visit will be compared between two groups. Finally, accuracy of this POC HCV RNA viral load testing in the acute care setting will be determined as compared to the standard-of-care clinical laboratory-based HCV RNA viral load testing. The investigators will also ask all of participants to grant permission to use the remnant blood specimens for an evaluation of future in-house HCV RNA viral load assay.",[28],[309,310],"viral load testing","point of care","2025-11-07",{"date":313,"type":37},"2025-11-10",{"date":315,"type":21},"2026-11",{"date":317,"type":21},"2027-11",{"name":295,"class":97},{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":52,"sex":53,"minAge":82,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":74},"100402865","liver-disease-and-other-systemic-diseases-100402865","NCT04525833","Liver Disease and Other Systemic Diseases","The Association of Liver Disease With Other Systemic Diseases, Focus on Diseases Progression, Treatments, and Clinical Outcomes: Analyses From the Hospital Database of Buddhist Tzu Chi Medical Foundation","Inclusion Criteria:\n\n* Individuals who visited the gastroenterology clinics of the Tzu Chi Hospitals, Buddhist Tzu Chi Medical Foundation\n\nExclusion Criteria:\n\n* Age younger than 18 or older than 99 years","99 Years",{"count":328,"type":21},15000,"Examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis, and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation.",[331,332,333,334,335,28,62,336,337,338],"Liver Diseases","Humans","Progression","Carcinogenesis","Fatty Liver Disease","Hepatocellular Carcinoma","Liver Cirrhoses","Treatment Outcome","2025-09-16",{"date":341,"type":37},"2025-09-19",{"date":343,"type":37},"2020-01-01",{"date":345,"type":21},"2026-12-31",{"name":347,"class":97},"Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation",{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":52,"sex":53,"minAge":355,"maxAge":4,"enrollmentInfo":356,"targetDuration":357,"studyType":58,"phases":4,"briefSummary":358,"conditions":359,"keywords":366,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":74},"100287699","blood-collection-biorepository-for-liver-disease-research-100287699","NCT03025074","Blood Collection Biorepository for Liver Disease Research","Virology, Immunology and Mechanisms of Liver Disease in Patients With Hepatitis C and Other Liver Diseases","Inclusion Criteria:\n\n* This protocol is to establish a biobank of blood samples from individuals with or without liver diseases including viral hepatitis, liver cancer, NASH, and negative control samples.\n* Children and teenagers will be special populations considered in this protocol.\n\nExclusion Criteria:\n\n* Vulnerable populations such as adults unable to consent, infants, pregnant women or prisoners will not be considered for this research study.","7 Years",{"count":107,"type":21},"1 Day","The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.",[360,28,62,361,362,363,364,365],"Non-Alcoholic Steatohepatitis(NASH)","Fibrosis","Cirrhosis","Fatty Liver","Obesity, Childhood","Bariatric Surgery Candidate",[63,367,368,30,369],"Obesity","Hepatitis","Hepatology","2025-08-20",{"date":372,"type":37},"2025-08-27",{"date":374,"type":4},"2013-07",{"date":376,"type":21},"2099-12",{"name":378,"class":97},"State University of New York at Buffalo",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":52,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":389,"conditions":390,"keywords":394,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":74},"100296200","project-i-test-implementing-hiv-testing-in-opioid-treatment-programs-100296200","NCT03135886","Project I Test: Implementing HIV Testing in Opioid Treatment Programs","A Cluster RCT to Increase HIV Testing in Substance Use Treatment Programs","Inclusion Criteria:\n\n* Eligible sites must:\n\n  1. See at least 150 unduplicated patients\u002Fyear\u002Fsite\n  2. Be capable and willing to prospectively collect data on the number of patients who a) are offered any HIV and\u002For HCV tests; b) completed these tests; c) are referred to care\u002Fevaluation (and type of referral) if positive; and d) are linked to care\u002Fevaluation within 30 days of diagnosis\n  3. Be capable and willing to provide patient demographics, testing data within demographic categories of gender and race\u002Fethnicity (in aggregate) and data on HIV\u002FHCV test reimbursement processes and outcomes\n  4. Have key staff willing to consent to participate in study surveys, qualitative interviews and intervention coaching throughout the study\n\nExclusion Criteria:\n\n* Sites will be excluded if:\n\n  1. Over 50% of patients served in the prior 6 months were HIV or HCV tested\n  2. They are terminated via PI decision\u002Fdiscretion",{"count":387,"type":21},418,[133],"This study will test two active evidence-based \"practice coaching\" (PC) interventions to improve opioid treatment programs' (OTPs') provision and sustained implementation of on-site 1) HIV testing and linkage to care and 2) HIV\u002FHepatitis C virus (HCV) testing and linkage to care among patients seeking\u002Freceiving substance use disorder treatment.\n\nAims are:\n\nAim 1: To evaluate the effectiveness of the PC interventions on improving patient uptake of HIV testing in OTPs including the incremental impact of the HIV\u002FHCV intervention on HIV testing.\n\nAim 2: To examine, using mixed-methods, the impact of the PC interventions on the initiation and sustained provision of HIV testing and timely linkage to care.\n\nAim 3: To evaluate the health outcomes, health care utilization, and cost-effectiveness of the PC interventions compared incrementally to one another and to the control condition.\n\nPrimary Hypothesis:\n\n1. The two PC interventions will result in significantly higher proportions of patients tested for HIV than the information control condition during the \"initial impact\" period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Primary) and during the \"sustained impact\" period, 13-18 months post-randomization or T4 (Secondary).\n2. The HIV\u002FHCV PC intervention will result in significantly higher proportions of patients tested for HIV than the HIV PC intervention during the initial impact period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Secondary) and during the \"sustained impact\" period, 13-18 months post-randomization or T4 (Secondary).",[391,28,392,393],"HIV\u002FAIDS","Substance Use Disorders","Opioid-use Disorder",[30,395,396,397,398,191,399],"HIV Testing","Hepatitis C Virus Testing","Opioid Use Disorder Treatment","Substance Use Disorders Treatment","Practice Coaching","2025-07-25",{"date":402,"type":37},"2025-07-29",{"date":404,"type":37},"2017-06-12",{"date":406,"type":21},"2026-07-31",{"name":408,"class":97},"Columbia University",{"id":410,"slug":411,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":52,"sex":417,"minAge":82,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":419,"conditions":420,"keywords":421,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":4},"100599532","pan-viral-screening-and-linkage-to-care-among-gbmsm-and-trans-women-in-spain-100599532","NCT07085715","Pan-Viral Screening and Linkage to Care Among GBMSM and Trans Women in Spain","Optimizing Pan-Viral Screening and Linkage to Treatment and Vaccination Among GBMSM and Trans Women in Spain, Including PrEP Users and Those Awaiting Access: An Online Self-Sampling Pilot Study","PAN-TESTATE","Inclusion Criteria:\n\n* Men self-reporting being gay, bisexual, and other men who have sex with men (GBMSM) or transgender women\n* 18 years old or older\n* Residing in Spain\n* Accepting to participate and signing the informed consent\n* Including those who are in PrEP or waiting access to PrEP; regardless of their HIV status (HIV-negative or HIV-positive), and considered at risk for HCV acute infection using the MOSAIC validated algorithm (score of 2 or higher).\n\nExclusion Criteria:\n\n* \\\u003C18 years old\n* No GBMSM or transgender women\n* Non-residents in Spain\n* No signing the informed consent\n* Not considered at risk for HCV acute infection using the MOSAIC validated algorithm (score lower than 2).","MALE",{"count":235,"type":21},"The World Health Organization (WHO) aims to eliminate viral hepatitis as a public health threat by 2030, with major reductions in hepatitis B and C incidence and mortality. However, hepatitis C virus (HCV) transmission has increased among gay, bisexual, and other men who have sex with men (GBMSM), especially those living with HIV. Practices such as chemsex, particularly involving injection drug use, have contributed to this rise. Hepatitis B virus (HBV) also remains a public health challenge due to the potential for chronic infection and severe liver damage. Hepatitis D virus (HDV), which requires HBV co-infection, further complicates clinical management.\n\nThis study aims to design, implement, and evaluate an online self-sampling testing strategy to enhance pan-viral testing (HBV, HCV, HDV, HIV) and improve linkage to care among GBMSM and transgender women (TW) in Spain.\n\nThe intervention will involve self-collected dried blood spot (DBS) samples for testing HBV surface antigen (HBsAg), HIV antibodies, and HCV RNA. Individuals testing positive for HBsAg will undergo further testing for HBV DNA and HDV infection. Those lacking protective levels of HBV antibodies will be referred for vaccination or revaccination.\n\nThe study will also assess the number of HIV-positive individuals who acquired the infection while waiting for access to PrEP, identifying missed prevention opportunities.\n\nThis non-randomized, single-arm, prospective national study will recruit adult GBMSM and TW through PrEP services, dating apps, NGOs, social media, and community outreach. Participants will complete an online risk assessment (using the HCV-MOSAIC algorithm) and receive self-sampling kits with instructions, lancets, Whatman cards, and prepaid envelopes. Results will be provided online, and those testing positive will be linked to confirmatory diagnosis and care.\n\nOutcomes include estimates of HIV, HBV, HCV, and HDV prevalence; effectiveness of linkage to care; acceptability and usability of the intervention; and validation of DBS for HBsAg detection.\n\nThis study will provide critical evidence on the effectiveness of online self-sampling strategies for viral hepatitis and HIV among GBMSM and TW, supporting Spain's public health goals for prevention, early diagnosis, and linkage to care.",[30,62,28],[422,423],"Self-sampling","Screening","2025-07-24",{"date":400,"type":37},{"date":427,"type":21},"2025-10",{"date":429,"type":21},"2026-12",{"name":431,"class":97},"Fundació Institut Germans Trias i Pujol",{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":444,"conditions":445,"keywords":447,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":461,"locationsCount":74},"100528341","early-phase-1-simplifying-hepatitis-c-pathways-for-people-who-inject-drugs-in-armenia-georgia-and-tanzania-100528341","NCT06159504","Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania","Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania (CUTTS HepC): a Non-randomised, Quasiexperimental, Prospective Comparative Trial","CUTTS HepC","Inclusion Criteria:\n\n* 18 years or older\n* Able and willing to provide informed consent in local language\n* Not currently on or previously had treatment for hepatitis C\n* Attending site for needle \u002F syringe program, OR self-reports ever injecting drugs\n\nExclusion Criteria:\n\n* Self-reported history of decompensate cirrhosis of the liver\n* Women who are pregnant or breast-feeding\n* Self-report other significant co-morbidities such as uncontrolled HIV infection, history of renal dysfunction, tuberculosis infection, or chronic hepatitis B infection\n* Unable \u002F unwilling to stop any contraindicated medications \u002F supplements",{"count":441,"type":21},3040,[443],"EARLY_PHASE1","The goal of this non-randomised, quasi-experimental, prospective comparative trial is to trial simplified care pathways for hepatitis C testing and treatment for people who inject drugs in Armenia, Georgia, and Tanzania.\n\nThe main questions it aims to answer are:\n\n1. What is the feasibility of implementing a hepatitis C simplified care and same-day treatment care model in community and harm reduction settings in the three study countries?\n2. Does a same-day treatment initiation model involving only POC antibody tests (with a shortened read-time) increase hepatitis C treatment uptake and SVR12 outcome (cure) among people who inject drugs compared with a simplified care model involving POC antibody followed by a confirmatory RNA test?\n3. What is the comparative cost-effectiveness between a same-day antibody only hepatitis C testing and treatment model and the simplified care model (POC antibody\u002Fconfirmatory RNA test) model?\n\nParticipants will:\n\n* be enrolled in a new simplified model of care in each country (Arm 1). After the enrolment target is met for Arm 1 (approx. 3-9 months into implementation) new participants will be enrolled into a same-day treatment trial, using presumptive treatment after a reactive POC test result at shortened read-time (5minutes) (Arm 2)\n* if in Arm 1, participants will commence SOF-VEL DAA treatment after receiving an RNA test to confirm current hepatitis C infection. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure.\n* if in Arm 2, participants will begin SOF-VEL DAA treatment on the same day as the 5 minute RDT testing. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure.\n\nResearchers will compare cure and participant retention rates between the two groups.",[28,446],"RDT",[448,449,450,451,452,453,454],"Point of care (PoC)","Nucleic acid testing","Qualitative interviews","Feasibility","Acceptability","Cost-effectiveness","Modelling","2025-07-15",{"date":457,"type":37},"2025-07-18",{"date":459,"type":37},"2024-10-03",{"date":429,"type":21},{"name":462,"class":97},"Médecins du Monde",{"id":464,"slug":465,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":474,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":74},"100529878","partner-navigation-intervention-for-hepatitis-c-treatment-among-young-people-who-inject-drugs-100529878","NCT06179498","Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs","A Randomized Trial to Test the Efficacy of a Partner Navigation Intervention for HCV Treatment Among Young Adult People Who Inject Drugs","Inclusion Criteria:\n\n* Self report injecting drugs in the past month\n* Self report a primary injecting partner (currently inject drugs together)\n* HCV infection identified at partnering community-based clinical site",{"count":235,"type":21},[133],"The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral intervention to increase hepatitis C (HCV) treatment initiation among adult people who inject drugs (PWID).",[28],[475],"Young people who inject drugs","2025-03-11",{"date":478,"type":37},"2025-03-13",{"date":480,"type":37},"2024-03-25",{"date":482,"type":21},"2027-06-01",{"name":484,"class":97},"University of California, San Francisco",{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":52,"sex":53,"minAge":4,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":495,"conditions":496,"keywords":497,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":74},"100467607","the-treatment-in-pregnancy-for-hepatitis-c-tip-hepc-registry-100467607","NCT05368974","The Treatment in Pregnancy for Hepatitis C (\"TiP-HepC\") Registry","An Observational Study of Mother-Infant Outcomes Following Antenatal Exposure to Direct-Acting Antivirals: the Treatment in Pregnancy for Hepatitis C (\"TiP-HepC\") Registry","TiP-HepC","Inclusion Criteria:\n\n-Documented pregnancy with: Estimated date of conception by documentation of either 1) date of last menstrual period or 2) ultrasound evaluation Actual date of delivery\n\n* Documented chronic HCV infection prior to or during pregnancy (positive test for HCV RNA or HCV core antigen)\n* Documented DAA exposure occurring within 30 days of the estimated date of conception and before the pregnancy outcome (ie, fetal demise, spontaneous abortion, live delivery, etc). Eligible DAA drugs are listed in Appendix 1.\n\nExclusion Criteria:\n\n\\- DAA exposures that include ribavirin or interferon will be excluded given their established harm during pregnancy.",{"count":494,"type":21},100,"Clinical interventions to reduce the risk of vertical transmission of hepatitis C virus (HCV) infection from mother to infant are highly limited. Direct-acting antiviral (DAA) medications have demonstrated excellent safety and efficacy in non-pregnant individuals, but there is a lack of data regarding the safety of these medications in pregnant women and the effectiveness of these medications in reducing mother-to-child transmission. Therefore, although HCV screening during pregnancy is now recommended in many countries, there is no approved treatment for HCV during pregnancy. An observational study is here proposed to assess outcomes of mother-infant pairs exposed to DAAs during pregnancy within a global clinical case registry. Data regarding the exposures and outcomes of mother-infant pairs exposed to DAAs during pregnancy will be solicited and collected from clinical providers, healthcare facilities, HCV treatment programs, and other clinical practices worldwide. Data will be shared and maintained within a secure database, and cumulative data will be analyzed at pre-determined six-month intervals. The primary outcome will be the number and proportion of mother-infant pairs with adverse pregnancy or birth outcomes. The results of this study will inform HCV treatment decisions by clinical providers and programs worldwide.",[28],[498,499],"pregnancy","hepatitis C","2024-12-13",{"date":502,"type":37},"2024-12-18",{"date":504,"type":37},"2022-02-11",{"date":506,"type":21},"2026-12-30",{"name":508,"class":97},"The Task Force for Global Health",{"id":510,"slug":511,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":52,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":74},"100553894","lay-user-evaluation-of-the-panbio-hcv-self-test-in-an-eu-population-100553894","NCT06492018","Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population","Inclusion Criteria:\n\n* Participant is aged 18 or over\n* Participant agrees to all aspects of the study and is able and willing to provide informed consent \u002F assent with parental consent.\n\nExclusion Criteria:\n\n* Participant has already participated in this study on a previous occasion.\n* Participant is deemed unfit for the study by the Investigator.\n* Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.\n* Participant is a practising health-care professional or laboratory scientist \u002F technician or has prior medical or laboratory training or experience\n* Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.\n* Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use.\n* Participant is unwilling or unable to provide informed consent.",{"count":516,"type":21},150,"This study is part of the performance evaluation to support the conformity assessment procedure for the use of fingerstick whole blood samples with Abbott's Panbio™ HCV Self Test device, as performed by lay users. The study will be conducted in accordance with the Commission Implementing Regulation (EU) 2022\u002F1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017\u002F746 of the European Parliament and of the Council and, to provide data to demonstrate the product is safe and effective for its intended use.",[28],[520,521,522,523],"Rapid diagnostic test","Antibodies to Hepatitis C Virus (HCV).","Self-test","Lay user","2024-11-20",{"date":526,"type":37},"2024-11-22",{"date":528,"type":21},"2024-12-01",{"date":530,"type":21},"2025-03-30",{"name":532,"class":533},"Abbott Rapid Dx","INDUSTRY",{"id":535,"slug":536,"hasResults":11,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":11,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":549,"leadSponsor":551,"locationsCount":4},"100557069","hepatitis-c-treatment-in-idaho-county-jails-100557069","NCT06533319","Hepatitis C Treatment in Idaho County Jails","Screening and Treatment for Chronic Hepatitis C Infection of Persons Incarcerated in the County Jail Setting","Inclusion Criteria:\n\n* All participants greater than 18 years old and incarcerated in an Idaho county jail greater than 10 days.\n* All participants who are not sentenced to prison terms at Idaho Department of Corrections (IDOC). Participants sentenced to IDOC will receive screening and treatment per IDOC policy.\n* Participants diagnosed with HCV and qualify for the AASLD Simplified Treatment Algorithm for Treatment Nave Adults Without Cirrhosis.\n\nExclusion Criteria:\n\n* All participants greater than 18 years old and incarcerated in an Idaho county jail greater than 10 days.\n* All participants who are not sentenced to prison terms at Idaho Department of Corrections (IDOC). Participants sentenced to IDOC will receive screening and treatment per IDOC policy.\n* Participants diagnosed with HCV and qualify for the AASLD Simplified Treatment Algorithm for Treatment Nave Adults Without Cirrhosis",{"count":494,"type":21},[133],"To explore the feasibility of opt in Hepatitis C Virus (HCV) screening and initiation of HCV treatment during incarceration in county jails including;\n\n1. incarcerated persons positive for HCV who remain in jail for duration of 12 weeks of treatment and\n2. incarcerated persons positive for HCV in jails less than the duration of 12 weeks of treatment who receive remaining supply of study drug on discharge with appropriate linkage to care.\n\nAssess quality of life measures in participants being treated for their HCV through the validated questionnaire EuroQol-5D at baseline and post-treatment.",[28],"2024-07-29",{"date":547,"type":37},"2024-08-01",{"date":547,"type":21},{"date":550,"type":21},"2025-08-01",{"name":552,"class":151},"Eastern Idaho Public Health",{"id":554,"slug":555,"hasResults":11,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":52,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":574,"locationsCount":575},"100494050","the-national-australian-hcv-point-of-care-testing-program---hcv-antibody-testing-minimal-dataset-100494050","NCT05713136","The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset","The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection - HCV Antibody Testing Minimal Dataset","Inclusion Criteria:\n\n* Provide informed consent\n* ≥ 18 years of age.\n\nExclusion Criteria:\n\n* Is unable or unwilling to provide informed consent",{"count":561,"type":21},40000,"The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is:\n\nWhat proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis?\n\nParticipants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit.\n\nNo treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.",[28],[565,566,567],"Point-of-Care","Rapid Diagnostic Testing","HCV","2024-07-02",{"date":570,"type":37},"2024-07-03",{"date":572,"type":37},"2023-01-25",{"date":248,"type":21},{"name":150,"class":151},12,{"id":577,"slug":578,"hasResults":11,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":52,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":584,"conditions":585,"keywords":586,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":593,"locationsCount":251},"100458356","the-national-australian-hcv-point-of-care-testing-program---minimal-dataset-100458356","NCT05248555","The National Australian HCV Point-of-Care Testing Program - Minimal Dataset","The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection - Minimal Dataset","Inclusion Criteria:\n\n* ≥ 18 years of age.\n* Received point-of-care HCV testing.\n\nExclusion Criteria:\n\n* Nil",{"count":561,"type":21},"The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). All participants who undergo HCV point-of-care testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.",[28],[191],"2024-06-11",{"date":589,"type":37},"2024-06-13",{"date":591,"type":37},"2021-12-01",{"date":429,"type":21},{"name":150,"class":151},{"id":595,"slug":596,"hasResults":11,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":52,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":604,"conditions":605,"keywords":610,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":74},"100467042","acceptability-of-simultaneous-screening-for-viral-hepatitis-b-c-and-hiv-among-drug-users-in-non-conventional-structures-100467042","NCT05361603","Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures","Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Facilities \"Outside the Walls\" Using the Dual Screening Method TROD (Rapid Diagnostic Tests) and FibroScan","SCANVIR","Inclusion Criteria:\n\n* Adult 18 and over\n* Patient frequenting an unconventional structure \"outside the walls\" or referred by a professional in the care sector\n* Patient who agreed to participate to the research\n\nExclusion Criteria:\n\n* Patient doesn't agree to participate to the research",{"count":603,"type":21},1500,"The principle is to propose dedicated monthly screening days bringing together the health personnel involved (hepatologist, addictologist, nurse in charge of the program, addictology nurse and social worker) and to propose appropriate management for each situation assessed.",[28,606,607,608,609],"Transmission, Intravenous Drug Abuser","Addiction, Alcohol","Addiction Opiate","Hepatitis C Virus Infection, Response to Therapy of",[499,611,612,30,613,614,615],"Elimination","HBV","PWID","Addiction","Care structure","2022-05-03",{"date":618,"type":37},"2022-05-04",{"date":620,"type":37},"2017-05-24",{"date":622,"type":21},"2030-02-14",{"name":624,"class":97},"University Hospital, Limoges",{"id":626,"slug":627,"hasResults":11,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":11,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":634,"conditions":635,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":74},"100258789","treatment-as-prevention-for-hepatitis-c-in-iceland-100258789","NCT02647879","Treatment as Prevention for Hepatitis C in Iceland","Treatment as Prevention for Hepatitis C in Iceland. A Nationwide Campaign for Reducing Disease Burden Using Combination Antiviral Treatment","TraPHepC","Inclusion Criteria:\n\n* HCV positive subjects 18 years and older, living in Iceland and covered by the Icelandic Health Insurance.\n\nExclusion Criteria:\n\n* Age under 18 years\n* Inability to sign informed consent.",{"count":107,"type":21},"The main aim of this study is to test in the Icelandic population the hypothesis that a nationwide treatment program which offers effective treatment to all known cases of Hepatitis C with the aim of halting HCV (Hepatitis C virus) transmission will lead to a reduction in incidence and disease burden associated with chronic HCV infection.",[28],"2020-09-24",{"date":638,"type":37},"2020-09-25",{"date":640,"type":4},"2016-01",{"date":642,"type":21},"2031-05",{"name":644,"class":97},"Landspitali University Hospital"]