[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489447":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":36,"responsibleParty":163,"collaborators":165,"id":169,"slug":170,"hasResults":171,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":171,"sex":177,"minAge":178,"maxAge":23,"enrollmentInfo":179,"targetDuration":23,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":23,"overallStatus":39,"whyStopped":23,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prophylaxis (P2W)","EXPERIMENTAL","Prophylaxis is one dose of sofosbuvir\u002Fvelpatasvir (SOF\u002FVEL) pre-HCV D+\u002FR- kidney transplant (KT), continued for 2 weeks.",[13],"Other: Prophylaxis (P2W)",{"label":15,"type":10,"description":16,"interventionNames":17},"Transmit and Treat (T&T)","T\\&T is study-supplied SOF\u002FVEL for 12 weeks starting on post-HCV D+\u002FR- kidney transplant day participant's insurance approves standard of care DAAs, or post-KT day 14, whichever comes first.",[18],"Other: Transmit and Treat (T&T)",[20,24],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"For participants enrolled in P2W arm, the initial dose of SOF\u002FVEL will be administered to the recipient when called to the operating room for transplant (typically 1-3 hours prior to the start of surgery). Post-transplant, SOF\u002FVEL will be continued daily for 13 days post-KT (a total of 14 doses administered).",[9],null,{"type":6,"name":15,"description":25,"armGroupLabels":26,"otherNames":23},"For participants enrolled in T\\&T arm, SOF\u002FVEL will begin between post-KT day 0 and post-KT day 14. Participants will be clinically-prescribed DAAs once viremia is detected, and participant's insurance will be petitioned to obtain treatment as soon as possible. If insurance-provided DAAs are approved before post-KT day 14, participant will begin 12 weeks of study-provided SOF\u002FVEL on date of insurance-provided DAAs approval. If insurance-provided DAAs are not approved by post-KT day 14, study-provided SOF\u002FVEL will begin on post-KT day 14 and continue for 12 weeks.",[15],[28],{"name":29,"affiliation":5,"role":30},"Christine Durand, MD","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":23,"email":35},"CONTACT","410-955-5684","cdurand2@jhmi.edu",[37,56,70,82,96,107,122,137,152],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University of California San Diego","RECRUITING","La Jolla","California","92037","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-117.2742,32.84727,{"lat":49,"lon":48},[52,55],{"name":53,"role":33,"phone":23,"phoneExt":23,"email":54},"Saima Aslam, MD","saslam@ucsd.edu",{"name":53,"role":30,"phone":23,"phoneExt":23,"email":23},{"facility":57,"status":39,"city":58,"state":41,"zip":59,"country":43,"countryCode":44,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Loma Linda University Health","Loma Linda","92408",{"type":46,"coordinates":61},[62,63],-117.26115,34.04835,{"lat":63,"lon":62},[66,69],{"name":67,"role":33,"phone":23,"phoneExt":23,"email":68},"Mina Rakoski, MD","mrakoski@llu.edu",{"name":67,"role":30,"phone":23,"phoneExt":23,"email":23},{"facility":5,"status":39,"city":71,"state":72,"zip":73,"country":43,"countryCode":44,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Baltimore","Maryland","21205",{"type":46,"coordinates":75},[76,77],-76.61219,39.29038,{"lat":77,"lon":76},[80,81],{"name":29,"role":33,"phone":34,"phoneExt":23,"email":35},{"name":29,"role":30,"phone":23,"phoneExt":23,"email":23},{"facility":83,"status":39,"city":84,"state":84,"zip":85,"country":43,"countryCode":44,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"NYU Langone Health","New York","10016",{"type":46,"coordinates":87},[88,89],-74.00597,40.71427,{"lat":89,"lon":88},[92,95],{"name":93,"role":33,"phone":23,"phoneExt":23,"email":94},"Aprajita Mattoo, MD","Aprajita.Matoo@nyulangone.org",{"name":93,"role":30,"phone":23,"phoneExt":23,"email":23},{"facility":97,"status":39,"city":84,"state":84,"zip":98,"country":43,"countryCode":44,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"Icahn School of Medicine at Mount Sinai","10029",{"type":46,"coordinates":100},[88,89],{"lat":89,"lon":88},[103,106],{"name":104,"role":33,"phone":23,"phoneExt":23,"email":105},"Susan Lerner, MD","Susan.Lerner@mountsinai.org",{"name":104,"role":30,"phone":23,"phoneExt":23,"email":23},{"facility":108,"status":39,"city":109,"state":110,"zip":111,"country":43,"countryCode":44,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15213",{"type":46,"coordinates":113},[114,115],-79.99589,40.44062,{"lat":115,"lon":114},[118,121],{"name":119,"role":33,"phone":23,"phoneExt":23,"email":120},"Fernanda Silveira, MD","silvfd@upmc.edu",{"name":119,"role":30,"phone":23,"phoneExt":23,"email":23},{"facility":123,"status":39,"city":124,"state":125,"zip":126,"country":43,"countryCode":44,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"University of Utah Medical Center","Salt Lake City","Utah","84132",{"type":46,"coordinates":128},[129,130],-111.89105,40.76078,{"lat":130,"lon":129},[133,136],{"name":134,"role":33,"phone":23,"phoneExt":23,"email":135},"Miklos Molnar, MD, PhD","miklos.molnar@hsc.utah.edu",{"name":134,"role":30,"phone":23,"phoneExt":23,"email":23},{"facility":138,"status":39,"city":139,"state":140,"zip":141,"country":43,"countryCode":44,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Virginia Commonwealth University","Richmond","Virginia","23298",{"type":46,"coordinates":143},[144,145],-77.46026,37.55376,{"lat":145,"lon":144},[148,151],{"name":149,"role":33,"phone":23,"phoneExt":23,"email":150},"Gaurav Gupta, MD","gaurav.gupta@vcuhealth.org",{"name":149,"role":30,"phone":23,"phoneExt":23,"email":23},{"facility":153,"status":154,"city":155,"state":156,"zip":157,"country":43,"countryCode":44,"cosmosGeoPoint":158,"geoPoint":162,"contacts":23},"University of Wisconsin, Madison","TERMINATED","Madison","Wisconsin","53792",{"type":46,"coordinates":159},[160,161],-89.40123,43.07305,{"lat":161,"lon":160},{"type":164,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[166],{"name":167,"class":168},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100489447","prophylaxis-with-direct-acting-antivirals-for-kidney-transplantation-from-hcv-infected-donors-to-uninfected-recipients-100489447",false,"NCT05653232","Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients","Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: a Randomized Controlled Trial","PREVENT-HCV","Inclusion Criteria:\n\n* Participant meets the standard criteria for KT at local center.\n* Participant is able to understand and provide informed consent.\n* Participant is ≥ 18 years old.\n\nExclusion Criteria:\n\n* Participant has active HCV infection (detectable HCV RNA) at time of screening.\n* Participant has cirrhosis or advanced liver fibrosis.\n* Participant's aspartate aminotransferase (AST) or ALT \\> 2.5 times the upper limit of normal (ULN), within 60 days of screen.\n* Participant has human immunodeficiency virus infection (HIV), or active hepatitis B (HBV) infection.\n* Participant is unable to safely substitute or discontinue a medication that is contraindicated with the study medication.\n* Past or current medical problems, which may pose additional risks from participation in the study, interfere with the participant's ability to comply with study, or impact the quality of the data obtained from the study.\n* Participant is pregnant or breastfeeding.","ALL","18 Years",{"count":180,"type":181},120,"ESTIMATED","INTERVENTIONAL",[184],"NA","This study is being done to find out the best time to start medication for Hepatitis C Virus (HCV) in HCV-negative recipients of HCV-positive (HCV D+\u002FR-) kidney transplants. Participants will be randomized into one of two groups:\n\nArm 1 - Prophylaxis: This group will start the HCV medication before transplant and will take a shorter course of HCV medication for 2 weeks.\n\nArm 2 - Transmit and Treat: This group will start the HCV medication after transplant and will take the full course (12 weeks) of HCV medication.",[187],"HCV","2026-02-13",{"date":190,"type":191},"2026-02-17","ACTUAL",{"date":193,"type":191},"2023-04-19",{"date":195,"type":181},"2027-03",{"name":5,"class":6},9]