[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100264733":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":27,"locations":28,"responsibleParty":215,"collaborators":27,"id":217,"slug":218,"hasResults":219,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":27,"eligibilityCriteria":223,"healthyVolunteers":224,"sex":225,"minAge":226,"maxAge":227,"enrollmentInfo":228,"targetDuration":27,"studyType":231,"phases":232,"briefSummary":234,"conditions":235,"keywords":27,"overallStatus":237,"whyStopped":27,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: 3 to \u003C24 months","EXPERIMENTAL","Participants weighing 5 to less than (\\\u003C) 7 kilogram (kg) received 25 milligram (mg) IVA, 7 to \\\u003C14 kg received 50 mg IVA, and those weighing 14 to \\\u003C25 kg received 75 mg IVA administered every 12 hours (q12h) on Days 1 through 3 and 1 morning dose on Day 4.",[13],"Drug: IVA",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B + A\u002FB:1 to \u003C 24 months","Participants 4 to \\\u003C6 months of age and weighing greater than or equal to (≥) 5 kg received 25 mg IVA q12h. At 6 months of age and older, participants weighing 5 to \\\u003C7 kg received 25 mg IVA, 7 to \\\u003C14 kg received 50 mg IVA, and those weighing 14 to \\\u003C25 kg received 75 mg IVA q12h for 24 weeks on Part B. For Part A\u002FB, participants 1 to \\\u003C4 months weighing 3 kg to \\\u003C5 kg received an initial low dose of 5.7 mg q12h IVA and those weighing ≥5 kg received 11.4 mg q12h IVA for the first 15 days of IVA treatment. Doses were maintained or adjusted upward at Day 15 and based on weight and\u002For age once they reached 4 months of age.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","IVA","Granules in sachet for oral administration.",[9,15],[25,26],"VX-770","ivacaftor",null,[29,40,48,56,64,72,80,88,96,104,112,120,128,136,146,153,160,169,178,187,194,201,208],{"facility":27,"status":27,"city":30,"state":31,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":27},"Birmingham","Alabama","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-86.80249,33.52066,{"lat":38,"lon":37},{"facility":27,"status":27,"city":41,"state":42,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":43,"geoPoint":47,"contacts":27},"Palo Alto","California",{"type":35,"coordinates":44},[45,46],-122.14302,37.44188,{"lat":46,"lon":45},{"facility":27,"status":27,"city":49,"state":50,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":51,"geoPoint":55,"contacts":27},"Atlanta","Georgia",{"type":35,"coordinates":52},[53,54],-84.38798,33.749,{"lat":54,"lon":53},{"facility":27,"status":27,"city":57,"state":58,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":59,"geoPoint":63,"contacts":27},"Chicago","Illinois",{"type":35,"coordinates":60},[61,62],-87.65005,41.85003,{"lat":62,"lon":61},{"facility":27,"status":27,"city":65,"state":66,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":67,"geoPoint":71,"contacts":27},"Indianapolis","Indiana",{"type":35,"coordinates":68},[69,70],-86.15804,39.76838,{"lat":70,"lon":69},{"facility":27,"status":27,"city":73,"state":74,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":75,"geoPoint":79,"contacts":27},"Baltimore","Maryland",{"type":35,"coordinates":76},[77,78],-76.61219,39.29038,{"lat":78,"lon":77},{"facility":27,"status":27,"city":81,"state":82,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":83,"geoPoint":87,"contacts":27},"Boston","Massachusetts",{"type":35,"coordinates":84},[85,86],-71.05977,42.35843,{"lat":86,"lon":85},{"facility":27,"status":27,"city":89,"state":90,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":91,"geoPoint":95,"contacts":27},"Kansas City","Missouri",{"type":35,"coordinates":92},[93,94],-94.57857,39.09973,{"lat":94,"lon":93},{"facility":27,"status":27,"city":97,"state":98,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":99,"geoPoint":103,"contacts":27},"Columbus","Ohio",{"type":35,"coordinates":100},[101,102],-82.99879,39.96118,{"lat":102,"lon":101},{"facility":27,"status":27,"city":105,"state":106,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":107,"geoPoint":111,"contacts":27},"Philadelphia","Pennsylvania",{"type":35,"coordinates":108},[109,110],-75.16362,39.95238,{"lat":110,"lon":109},{"facility":27,"status":27,"city":113,"state":114,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":115,"geoPoint":119,"contacts":27},"Houston","Texas",{"type":35,"coordinates":116},[117,118],-95.36327,29.76328,{"lat":118,"lon":117},{"facility":27,"status":27,"city":121,"state":122,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":123,"geoPoint":127,"contacts":27},"Seattle","Washington",{"type":35,"coordinates":124},[125,126],-122.33207,47.60621,{"lat":126,"lon":125},{"facility":27,"status":27,"city":129,"state":130,"zip":27,"country":32,"countryCode":33,"cosmosGeoPoint":131,"geoPoint":135,"contacts":27},"Madison","Wisconsin",{"type":35,"coordinates":132},[133,134],-89.40123,43.07305,{"lat":134,"lon":133},{"facility":27,"status":27,"city":137,"state":138,"zip":27,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":145,"contacts":27},"Parkville","Victoria","Australia","AU",{"type":35,"coordinates":142},[143,144],144.95,-37.78333,{"lat":144,"lon":143},{"facility":27,"status":27,"city":147,"state":27,"zip":27,"country":139,"countryCode":140,"cosmosGeoPoint":148,"geoPoint":152,"contacts":27},"South Brisbane",{"type":35,"coordinates":149},[150,151],153.02049,-27.48034,{"lat":151,"lon":150},{"facility":27,"status":27,"city":154,"state":27,"zip":27,"country":139,"countryCode":140,"cosmosGeoPoint":155,"geoPoint":159,"contacts":27},"Westmead",{"type":35,"coordinates":156},[157,158],150.98768,-33.80383,{"lat":158,"lon":157},{"facility":27,"status":27,"city":161,"state":27,"zip":27,"country":162,"countryCode":163,"cosmosGeoPoint":164,"geoPoint":168,"contacts":27},"Toronto","Canada","CA",{"type":35,"coordinates":165},[166,167],-79.39864,43.70643,{"lat":167,"lon":166},{"facility":27,"status":27,"city":170,"state":27,"zip":27,"country":171,"countryCode":172,"cosmosGeoPoint":173,"geoPoint":177,"contacts":27},"Dublin","Ireland","IE",{"type":35,"coordinates":174},[175,176],-6.24889,53.33306,{"lat":176,"lon":175},{"facility":27,"status":27,"city":179,"state":27,"zip":27,"country":180,"countryCode":181,"cosmosGeoPoint":182,"geoPoint":186,"contacts":27},"Edinburgh","United Kingdom","UK",{"type":35,"coordinates":183},[184,185],-3.19648,55.95206,{"lat":185,"lon":184},{"facility":27,"status":27,"city":188,"state":27,"zip":27,"country":180,"countryCode":181,"cosmosGeoPoint":189,"geoPoint":193,"contacts":27},"Leicester",{"type":35,"coordinates":190},[191,192],-1.13169,52.6386,{"lat":192,"lon":191},{"facility":27,"status":27,"city":195,"state":27,"zip":27,"country":180,"countryCode":181,"cosmosGeoPoint":196,"geoPoint":200,"contacts":27},"London",{"type":35,"coordinates":197},[198,199],-0.12574,51.50853,{"lat":199,"lon":198},{"facility":27,"status":27,"city":202,"state":27,"zip":27,"country":180,"countryCode":181,"cosmosGeoPoint":203,"geoPoint":207,"contacts":27},"Manchester",{"type":35,"coordinates":204},[205,206],-2.23743,53.48095,{"lat":206,"lon":205},{"facility":27,"status":27,"city":209,"state":27,"zip":27,"country":180,"countryCode":181,"cosmosGeoPoint":210,"geoPoint":214,"contacts":27},"Oxford",{"type":35,"coordinates":211},[212,213],-1.25596,51.75222,{"lat":213,"lon":212},{"type":216,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100264733","phase-3-a-study-to-evaluate-the-safety-pharmacokinetics-and-pharmacodynamics-of-ivacaftor-in-subjects-with-cystic-fibrosis-who-are-less-than-24-months-of-age-and-have-an-ivacaftor-responsive-cftr-mutation-100264733",true,"NCT02725567","A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation","A Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation","Inclusion Criteria:\n\n* Confirmed diagnosis of CF by sweat chloride value or CF mutation criteria.\n* Have 1 of the following 10 CFTR mutations on at least 1 allele: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D or R117H (eligible in regions where ivacaftor is approved for use). Part A\u002FB group may also have other ivacaftor-responsive mutations.\n* Hematology, serum chemistry, and vital signs results at screening with no clinically significant abnormalities that would interfere with the study assessments, as judged by the investigator.\n\nExclusion Criteria:\n\n* History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant\n* Colonization with organisms associated with a more rapid decline in pulmonary status at screening (Only for Parts A and B)\n* History of abnormal liver function or abnormal liver function at screening\n* History of solid organ or hematological transplantation\n* Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A within 2 weeks before Day 1\n* Participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives before screening\n* Hemoglobin (Hgb) \\\u003C9.5 g\u002FdL at screening\n* Chronic kidney disease of Stage 3 or above\n* Presence of a non-congenital or progressive lens opacity or cataract at Screening\n\nOther protocol defined Inclusion\u002FExclusion Criteria may apply.",false,"ALL","1 Month","24 Months",{"count":229,"type":230},57,"ACTUAL","INTERVENTIONAL",[233],"PHASE3","The purpose of this study was to evaluate the safety of ivacaftor treatment, and PK of ivacaftor and metabolites in participants with cystic fibrosis (CF) who are \\\u003C24 months of age at treatment initiation and have an ivacaftor-responsive CF transmembrane conductance regulator (CFTR) gene mutation.",[236],"Cystic Fibrosis","COMPLETED","2023-08-14",{"date":240,"type":230},"2023-09-07",{"date":242,"type":230},"2016-06-02",{"date":244,"type":230},"2022-06-28",{"name":5,"class":6},23]