[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504143":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":23,"locations":24,"responsibleParty":374,"collaborators":23,"id":376,"slug":377,"hasResults":378,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":23,"eligibilityCriteria":382,"healthyVolunteers":378,"sex":383,"minAge":384,"maxAge":23,"enrollmentInfo":385,"targetDuration":23,"studyType":388,"phases":389,"briefSummary":391,"conditions":392,"keywords":23,"overallStatus":394,"whyStopped":23,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":404},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"VNZ\u002FTEZ\u002FD-IVA","EXPERIMENTAL","Part A: Participants (Cohort 1: 6 through 11 years of age (inclusive); Cohort 2: 2 through 5 years of age (inclusive) and Cohort 3: 1 to less than (\\\u003C) 2 years of age) will receive VNZ\u002FTEZ\u002FD-IVA once daily at doses determined based on their age and weight. The age range is based on date of informed consent in parent study.\n\nPart B: Participants in Cohort 1 who meet the eligibility criteria will receive VNZ\u002FTEZ\u002FD-IVA for an additional 96 weeks.",[13],"Drug: VNZ\u002FTEZ\u002FD-IVA",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Fixed-dose combination tablets or granules for oral administration.",[9],[20,21,22],"VX-121\u002FVX-661\u002FVX-561","VX-121\u002FVX-661\u002FCTP-656","vanzacaftor\u002Ftezacaftor\u002Fdeutivacaftor",null,[25,38,47,57,67,77,87,97,107,117,126,136,146,155,164,174,184,194,204,214,222,230,238,248,256,266,274,284,292,300,310,320,330,338,348,356,366],{"facility":26,"status":23,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":23},"Children's Hospital of Orange County","Orange","California","92868","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-117.85311,33.78779,{"lat":36,"lon":35},{"facility":39,"status":23,"city":40,"state":28,"zip":41,"country":30,"countryCode":31,"cosmosGeoPoint":42,"geoPoint":46,"contacts":23},"Stanford University - Palo Alto - Pulmonology","Palo Alto","94304",{"type":33,"coordinates":43},[44,45],-122.14302,37.44188,{"lat":45,"lon":44},{"facility":48,"status":23,"city":49,"state":50,"zip":51,"country":30,"countryCode":31,"cosmosGeoPoint":52,"geoPoint":56,"contacts":23},"Children's Hospital of Colorado - Pulmonology","Aurora","Colorado","80045",{"type":33,"coordinates":53},[54,55],-104.83192,39.72943,{"lat":55,"lon":54},{"facility":58,"status":23,"city":59,"state":60,"zip":61,"country":30,"countryCode":31,"cosmosGeoPoint":62,"geoPoint":66,"contacts":23},"The Emory Clinic - Clifton Road - Pulmonology","Atlanta","Georgia","30322",{"type":33,"coordinates":63},[64,65],-84.38798,33.749,{"lat":65,"lon":64},{"facility":68,"status":23,"city":69,"state":70,"zip":71,"country":30,"countryCode":31,"cosmosGeoPoint":72,"geoPoint":76,"contacts":23},"Ann & Robert H. Lurie Children's Hospital of Chicago - Hematology","Chicago","Illinois","60611",{"type":33,"coordinates":73},[74,75],-87.65005,41.85003,{"lat":75,"lon":74},{"facility":78,"status":23,"city":79,"state":80,"zip":81,"country":30,"countryCode":31,"cosmosGeoPoint":82,"geoPoint":86,"contacts":23},"JW Riley Hospital for Children - Pulmonology","Indianapolis","Indiana","46202",{"type":33,"coordinates":83},[84,85],-86.15804,39.76838,{"lat":85,"lon":84},{"facility":88,"status":23,"city":89,"state":90,"zip":91,"country":30,"countryCode":31,"cosmosGeoPoint":92,"geoPoint":96,"contacts":23},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":33,"coordinates":93},[94,95],-71.05977,42.35843,{"lat":95,"lon":94},{"facility":98,"status":23,"city":99,"state":100,"zip":101,"country":30,"countryCode":31,"cosmosGeoPoint":102,"geoPoint":106,"contacts":23},"Children's Health Care d\u002Fb\u002Fa Children's Hospitals and Clinics of Minnesota","Minneapolis","Minnesota","55404",{"type":33,"coordinates":103},[104,105],-93.26384,44.97997,{"lat":105,"lon":104},{"facility":108,"status":23,"city":109,"state":110,"zip":111,"country":30,"countryCode":31,"cosmosGeoPoint":112,"geoPoint":116,"contacts":23},"The Children's Mercy Hospital","Kansas City","Missouri","64108",{"type":33,"coordinates":113},[114,115],-94.57857,39.09973,{"lat":115,"lon":114},{"facility":118,"status":23,"city":119,"state":110,"zip":120,"country":30,"countryCode":31,"cosmosGeoPoint":121,"geoPoint":125,"contacts":23},"St. Louis Children's Hospital - 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Pulmonology","Pittsburgh","Pennsylvania","15224",{"type":33,"coordinates":170},[171,172],-79.99589,40.44062,{"lat":172,"lon":171},{"facility":175,"status":23,"city":176,"state":177,"zip":178,"country":30,"countryCode":31,"cosmosGeoPoint":179,"geoPoint":183,"contacts":23},"Texas Children's Hospital - Wallace Tower - Pulmonology","Houston","Texas","77030",{"type":33,"coordinates":180},[181,182],-95.36327,29.76328,{"lat":182,"lon":181},{"facility":185,"status":23,"city":186,"state":187,"zip":188,"country":30,"countryCode":31,"cosmosGeoPoint":189,"geoPoint":193,"contacts":23},"Vermont Lung Center","Colchester","Vermont","05446",{"type":33,"coordinates":190},[191,192],-73.14791,44.54394,{"lat":192,"lon":191},{"facility":195,"status":23,"city":196,"state":197,"zip":198,"country":30,"countryCode":31,"cosmosGeoPoint":199,"geoPoint":203,"contacts":23},"American Family Childrens Hospital","Madison","Wisconsin","53792",{"type":33,"coordinates":200},[201,202],-89.40123,43.07305,{"lat":202,"lon":201},{"facility":205,"status":23,"city":206,"state":23,"zip":23,"country":207,"countryCode":208,"cosmosGeoPoint":209,"geoPoint":213,"contacts":23},"The Kids Research Institute Australia","Nedlands","Australia","AU",{"type":33,"coordinates":210},[211,212],115.8073,-31.98184,{"lat":212,"lon":211},{"facility":215,"status":23,"city":216,"state":23,"zip":23,"country":207,"countryCode":208,"cosmosGeoPoint":217,"geoPoint":221,"contacts":23},"Women's & Children's Hospital","North Adelaide",{"type":33,"coordinates":218},[219,220],138.59141,-34.90733,{"lat":220,"lon":219},{"facility":223,"status":23,"city":224,"state":23,"zip":23,"country":207,"countryCode":208,"cosmosGeoPoint":225,"geoPoint":229,"contacts":23},"The Royal Children's Hospital Melbourne","Parkville",{"type":33,"coordinates":226},[227,228],144.95,-37.78333,{"lat":228,"lon":227},{"facility":231,"status":23,"city":232,"state":23,"zip":23,"country":207,"countryCode":208,"cosmosGeoPoint":233,"geoPoint":237,"contacts":23},"Children's Health Queensland Hospital and Health Service","South Brisbane",{"type":33,"coordinates":234},[235,236],153.02049,-27.48034,{"lat":236,"lon":235},{"facility":239,"status":23,"city":240,"state":23,"zip":23,"country":241,"countryCode":242,"cosmosGeoPoint":243,"geoPoint":247,"contacts":23},"Hospital for Sick Children - 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Pulmonology","Stockholm",{"type":33,"coordinates":334},[335,336],18.06871,59.32938,{"lat":336,"lon":335},{"facility":339,"status":23,"city":340,"state":23,"zip":23,"country":341,"countryCode":342,"cosmosGeoPoint":343,"geoPoint":347,"contacts":23},"Inselspital Bern","Bern","Switzerland","CH",{"type":33,"coordinates":344},[345,346],7.44744,46.94809,{"lat":346,"lon":345},{"facility":349,"status":23,"city":350,"state":23,"zip":23,"country":341,"countryCode":342,"cosmosGeoPoint":351,"geoPoint":355,"contacts":23},"Kinderspital Zurich - Abteilung Pneumologie","Zurich",{"type":33,"coordinates":352},[353,354],8.55,47.36667,{"lat":354,"lon":353},{"facility":357,"status":23,"city":358,"state":23,"zip":23,"country":359,"countryCode":360,"cosmosGeoPoint":361,"geoPoint":365,"contacts":23},"Noah's Ark Children's Hospital for Wales","Cardiff","United Kingdom","UK",{"type":33,"coordinates":362},[363,364],-3.18,51.48,{"lat":364,"lon":363},{"facility":367,"status":23,"city":368,"state":23,"zip":23,"country":359,"countryCode":360,"cosmosGeoPoint":369,"geoPoint":373,"contacts":23},"Great Ormond Street Hospital for Children","London",{"type":33,"coordinates":370},[371,372],-0.12574,51.50853,{"lat":372,"lon":371},{"type":375,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100504143","phase-3-evaluation-of-long-term-safety-and-efficacy-of-vanzacaftortezacaftordeutivacaftor-in-cystic-fibrosis-participants-1-year-of-age-and-older-100504143",false,"NCT05844449","Evaluation of Long-Term Safety and Efficacy of Vanzacaftor\u002FTezacaftor\u002FDeutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older","A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of Vanzacaftor\u002FTezacaftor\u002FDeutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Year of Age and Older","Key Inclusion Criteria:\n\nParts A and B:\n\n• Participants who have completed study drug treatment in the parent study (VX21-121-105; NCT Number: NCT05422222)\n\nPart B:\n\n-Meets at least 1 of the following criteria:\n\n* Completed study drug treatment in Part A\n* Had study drug interruption(s) in Part A, but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the treatment period of Part A\n\nKey Exclusion Criteria:\n\n* Hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe hepatic impairment that might pose an additional risk in administering study drug\n* History of solid organ, hematological transplantation, or cancer\n* History of drug intolerance in the parent study\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","1 Year",{"count":386,"type":387},174,"ESTIMATED","INTERVENTIONAL",[390],"PHASE3","The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of vanzacaftor\u002Ftezacaftor\u002Fdeutivacaftor (VNZ\u002FTEZ\u002FD-IVA) in participants with cystic fibrosis (CF).",[393],"Cystic Fibrosis","ENROLLING_BY_INVITATION","2026-04-23",{"date":397,"type":398},"2026-04-29","ACTUAL",{"date":400,"type":398},"2023-08-11",{"date":402,"type":387},"2029-07-30",{"name":5,"class":6},37]