[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05844449":3,"trial-entities:NCT05844449":395,"trial-summary:NCT05844449":398},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":37,"secondary_outcomes":44,"sex":109,"minimum_age":110,"maximum_age":15,"healthy_volunteers":111,"eligibility_criteria":112,"std_ages":122,"locations":126,"central_contacts":391,"overall_officials":392,"references":393,"see_also_links":394},"NCT05844449","VX22-121-106","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","ENROLLING_BY_INVITATION","2029-07-30","2026-04","2026-04-29","2023-08-11","Vertex Pharmaceuticals Incorporated","INDUSTRY",null,"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).",[18],"Cystic Fibrosis",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE3",{"count":25,"type":26},174,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","VNZ\u002FTEZ\u002FD-IVA","Fixed-dose combination tablets or granules for oral administration.",[30],[34,35,36],"VX-121\u002FVX-661\u002FVX-561","VX-121\u002FVX-661\u002FCTP-656","vanzacaftor\u002Ftezacaftor\u002Fdeutivacaftor",[38,41],{"measure":39,"timeFrame":40},"Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)","From Baseline up to Week 100",{"measure":42,"timeFrame":43},"Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)","From Baseline up to Week 196",[45,48,51,54,57,59,61,63,65,67,69,71,73,75,77,79,81,83,85,87,89,91,93,95,97,99,101,103,105,107],{"measure":46,"timeFrame":47},"Part A (All Cohorts): Absolute Change in Sweat Chloride (SwCl)","From Baseline Through Week 96",{"measure":49,"timeFrame":50},"Part B: Absolute Change in Sweat Chloride (SwCl)","From Baseline Through Week 192",{"measure":52,"timeFrame":53},"Part A (Cohort 1): Absolute Change in Percent Predicted Forced Expiratory Volume (ppFEV1)","From Baseline Through Week 100",{"measure":55,"timeFrame":56},"Part B: Absolute Change in Percent Predicted Forced Expiratory Volume (ppFEV1)","From Baseline Through Week 196",{"measure":58,"timeFrame":53},"Part A (All Cohorts): Number of Pulmonary Exacerbation (PEx)",{"measure":60,"timeFrame":56},"Part B: Number of Pulmonary Exacerbation (PEx)",{"measure":62,"timeFrame":53},"Part A (All Cohorts): Number of CF- Related Hospitalizations",{"measure":64,"timeFrame":56},"Part B: Number of CF- Related Hospitalizations",{"measure":66,"timeFrame":53},"Part A (Cohort 1): Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain (RD) Score",{"measure":68,"timeFrame":56},"Part B: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain (RD) Score",{"measure":70,"timeFrame":53},"Part A (Cohorts 1 and 2): Absolute Change in Body Mass Index (BMI)",{"measure":72,"timeFrame":56},"Part B: Absolute Change in Body Mass Index (BMI)",{"measure":74,"timeFrame":53},"Part A (Cohorts 1 and 2): Absolute Change in BMI-for-age Z-score",{"measure":76,"timeFrame":56},"Part B: Absolute Change in BMI-for-age Z-score",{"measure":78,"timeFrame":53},"Part A (Cohort 3): Absolute Change in Weight-for-length",{"measure":80,"timeFrame":56},"Part B: Absolute Change in Weight-for-length",{"measure":82,"timeFrame":53},"Part A (Cohort 3): Absolute Change in Weight-for-length Z-score",{"measure":84,"timeFrame":56},"Part B: Absolute Change in Weight-for-length Z-score",{"measure":86,"timeFrame":53},"Part A (All Cohorts): Absolute Change in Weight",{"measure":88,"timeFrame":56},"Part B: Absolute Change in Weight",{"measure":90,"timeFrame":53},"Part A (All Cohorts): Change in Weight-for-age Z-score",{"measure":92,"timeFrame":56},"Part B: Change in Weight-for-age Z-score",{"measure":94,"timeFrame":53},"Part A (Cohorts 1 and 2): Absolute Change in Height",{"measure":96,"timeFrame":56},"Part B: Absolute Change in Height",{"measure":98,"timeFrame":53},"Part A (Cohorts 1 and 2): Absolute Change in Height-for-age Z-score",{"measure":100,"timeFrame":56},"Part B: Absolute Change in Height-for-age Z-score",{"measure":102,"timeFrame":53},"Part A (Cohort 3): Absolute Change in Length",{"measure":104,"timeFrame":56},"Part B: Absolute Change in Length",{"measure":106,"timeFrame":53},"Part A (Cohort 3): Absolute Change in Length-for-age Z-score",{"measure":108,"timeFrame":56},"Part B: Absolute Change in Length-for-age Z-score","ALL","1 Year",false,{"inclusion":113,"exclusion":117,"raw_text":121},[114,115,116],"Meets at least 1 of the following criteria:","Completed study drug treatment in Part A","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",[118,119,120],"Hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe hepatic impairment that might pose an additional risk in administering study drug","History of solid organ, hematological transplantation, or cancer","History of drug intolerance in the parent study","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.",[123,124,125],"CHILD","ADULT","OLDER_ADULT",[127,136,143,151,159,167,175,183,191,199,206,214,222,229,236,244,252,260,268,275,281,287,293,300,306,313,319,326,332,338,345,352,359,365,372,378,385],{"facility":128,"city":129,"state":130,"zip":131,"country":132,"geoPoint":133},"Children's Hospital of Orange County","Orange","California","92868","United States",{"lat":134,"lon":135},33.78779,-117.85311,{"facility":137,"city":138,"state":130,"zip":139,"country":132,"geoPoint":140},"Stanford University - Palo Alto - Pulmonology","Palo Alto","94304",{"lat":141,"lon":142},37.44188,-122.14302,{"facility":144,"city":145,"state":146,"zip":147,"country":132,"geoPoint":148},"Children's Hospital of Colorado - Pulmonology","Aurora","Colorado","80045",{"lat":149,"lon":150},39.72943,-104.83192,{"facility":152,"city":153,"state":154,"zip":155,"country":132,"geoPoint":156},"The Emory Clinic - Clifton Road - Pulmonology","Atlanta","Georgia","30322",{"lat":157,"lon":158},33.749,-84.38798,{"facility":160,"city":161,"state":162,"zip":163,"country":132,"geoPoint":164},"Ann & Robert H. Lurie Children's Hospital of Chicago - Hematology","Chicago","Illinois","60611",{"lat":165,"lon":166},41.85003,-87.65005,{"facility":168,"city":169,"state":170,"zip":171,"country":132,"geoPoint":172},"JW Riley Hospital for Children - Pulmonology","Indianapolis","Indiana","46202",{"lat":173,"lon":174},39.76838,-86.15804,{"facility":176,"city":177,"state":178,"zip":179,"country":132,"geoPoint":180},"Boston Children's Hospital","Boston","Massachusetts","02115",{"lat":181,"lon":182},42.35843,-71.05977,{"facility":184,"city":185,"state":186,"zip":187,"country":132,"geoPoint":188},"Children's Health Care d\u002Fb\u002Fa Children's Hospitals and Clinics of Minnesota","Minneapolis","Minnesota","55404",{"lat":189,"lon":190},44.97997,-93.26384,{"facility":192,"city":193,"state":194,"zip":195,"country":132,"geoPoint":196},"The Children's Mercy Hospital","Kansas City","Missouri","64108",{"lat":197,"lon":198},39.09973,-94.57857,{"facility":200,"city":201,"state":194,"zip":202,"country":132,"geoPoint":203},"St. Louis Children's Hospital - Pulmonology","St Louis","63110",{"lat":204,"lon":205},38.62727,-90.19789,{"facility":207,"city":208,"state":209,"zip":210,"country":132,"geoPoint":211},"Cohen Children's Medical Center - Lakeville Road","Lake Success","New York","11042",{"lat":212,"lon":213},40.77066,-73.71763,{"facility":215,"city":216,"state":217,"zip":218,"country":132,"geoPoint":219},"Cincinnati Children's Hospital Medical Center - Pulmonology","Cincinnati","Ohio","45229",{"lat":220,"lon":221},39.12711,-84.51439,{"facility":223,"city":224,"state":217,"zip":225,"country":132,"geoPoint":226},"UH Cleveland Medical Center - Pulmonology","Cleveland","44106",{"lat":227,"lon":228},41.4995,-81.69541,{"facility":230,"city":231,"state":217,"zip":232,"country":132,"geoPoint":233},"Nationwide Children's Hospital","Columbus","43205",{"lat":234,"lon":235},39.96118,-82.99879,{"facility":237,"city":238,"state":239,"zip":240,"country":132,"geoPoint":241},"Children's Hospital of Pittsburgh - Pulmonology","Pittsburgh","Pennsylvania","15224",{"lat":242,"lon":243},40.44062,-79.99589,{"facility":245,"city":246,"state":247,"zip":248,"country":132,"geoPoint":249},"Texas Children's Hospital - Wallace Tower - Pulmonology","Houston","Texas","77030",{"lat":250,"lon":251},29.76328,-95.36327,{"facility":253,"city":254,"state":255,"zip":256,"country":132,"geoPoint":257},"Vermont Lung Center","Colchester","Vermont","05446",{"lat":258,"lon":259},44.54394,-73.14791,{"facility":261,"city":262,"state":263,"zip":264,"country":132,"geoPoint":265},"American Family Childrens Hospital","Madison","Wisconsin","53792",{"lat":266,"lon":267},43.07305,-89.40123,{"facility":269,"city":270,"country":271,"geoPoint":272},"The Kids Research Institute Australia","Nedlands","Australia",{"lat":273,"lon":274},-31.98184,115.8073,{"facility":276,"city":277,"country":271,"geoPoint":278},"Women's & Children's Hospital","North Adelaide",{"lat":279,"lon":280},-34.90733,138.59141,{"facility":282,"city":283,"country":271,"geoPoint":284},"The Royal Children's Hospital Melbourne","Parkville",{"lat":285,"lon":286},-37.78333,144.95,{"facility":288,"city":289,"country":271,"geoPoint":290},"Children's Health Queensland Hospital and Health Service","South Brisbane",{"lat":291,"lon":292},-27.48034,153.02049,{"facility":294,"city":295,"country":296,"geoPoint":297},"Hospital for Sick Children - Pulmonology","Toronto","Canada",{"lat":298,"lon":299},43.70643,-79.39864,{"facility":301,"city":302,"country":296,"geoPoint":303},"British Columbia Children's Hospital","Vancouver",{"lat":304,"lon":305},49.24966,-123.11934,{"facility":307,"city":308,"country":309,"geoPoint":310},"Hopital Femme Mere-Enfant","Bron","France",{"lat":311,"lon":312},45.73865,4.91303,{"facility":314,"city":315,"country":309,"geoPoint":316},"Hopital Necker Enfants Malades - Pulmonology","Paris",{"lat":317,"lon":318},48.85341,2.3488,{"facility":320,"city":321,"country":322,"geoPoint":323},"Charite Paediatric Pulmonology Department","Berlin","Germany",{"lat":324,"lon":325},52.52437,13.41053,{"facility":327,"city":328,"country":322,"geoPoint":329},"Universitatsklinikum Essen","Essen",{"lat":330,"lon":331},51.45657,7.01228,{"facility":333,"city":334,"country":322,"geoPoint":335},"Medizinische Hochschule Hannover - Clinic for Pediatric Pneumology, Allergology and Neonatology, CF-Centre","Hanover",{"lat":336,"lon":337},52.37052,9.73322,{"facility":339,"city":340,"country":341,"geoPoint":342},"Sophia Children's Hospital","Rotterdam","Netherlands",{"lat":343,"lon":344},51.9225,4.47917,{"facility":346,"city":347,"country":348,"geoPoint":349},"Starship Child Health","Grafton","New Zealand",{"lat":350,"lon":351},-36.86029,174.76566,{"facility":353,"city":354,"country":355,"geoPoint":356},"Sahlgrenska Universitetssjukhuset - Göteborg CF-center","Gothenburg","Sweden",{"lat":357,"lon":358},57.70716,11.96679,{"facility":360,"city":361,"country":355,"geoPoint":362},"Karolinska University Hospital - Pulmonology","Stockholm",{"lat":363,"lon":364},59.32938,18.06871,{"facility":366,"city":367,"country":368,"geoPoint":369},"Inselspital Bern","Bern","Switzerland",{"lat":370,"lon":371},46.94809,7.44744,{"facility":373,"city":374,"country":368,"geoPoint":375},"Kinderspital Zurich - Abteilung Pneumologie","Zurich",{"lat":376,"lon":377},47.36667,8.55,{"facility":379,"city":380,"country":381,"geoPoint":382},"Noah's Ark Children's Hospital for Wales","Cardiff","United Kingdom",{"lat":383,"lon":384},51.48,-3.18,{"facility":386,"city":387,"country":381,"geoPoint":388},"Great Ormond Street Hospital for Children","London",{"lat":389,"lon":390},51.50853,-0.12574,[],[],[],[],{"nct_id":4,"conditions":396,"biomarkers":397},[18],[],{"nct_id":4,"found":111,"summary":15,"prompt_version":15}]