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248640","Valhalla","10595",{"type":67,"coordinates":184},[185,186],-73.77513,41.07482,{"lat":186,"lon":185},{"facility":189,"status":37,"city":190,"state":191,"zip":192,"country":64,"countryCode":65,"cosmosGeoPoint":193,"geoPoint":197,"contacts":37},"UH Cleveland Medical Center \u002FID# 245433","Cleveland","Ohio","44106",{"type":67,"coordinates":194},[195,196],-81.69541,41.4995,{"lat":196,"lon":195},{"facility":199,"status":37,"city":200,"state":191,"zip":201,"country":64,"countryCode":65,"cosmosGeoPoint":202,"geoPoint":206,"contacts":37},"ProMedica Toledo Harris McIntosh \u002FID# 248627","Toledo","43606-3845",{"type":67,"coordinates":203},[204,205],-83.55521,41.66394,{"lat":205,"lon":204},{"facility":208,"status":37,"city":209,"state":210,"zip":211,"country":64,"countryCode":65,"cosmosGeoPoint":212,"geoPoint":216,"contacts":37},"University of Oklahoma HSC \u002FID# 249190","Oklahoma 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Capital","1090",{"type":67,"coordinates":365},[366,367],4.33419,50.87309,{"lat":367,"lon":366},{"facility":370,"status":37,"city":371,"state":372,"zip":373,"country":352,"countryCode":353,"cosmosGeoPoint":374,"geoPoint":378,"contacts":37},"UZ Gent \u002FID# 226605","Ghent","Oost-Vlaanderen","9000",{"type":67,"coordinates":375},[376,377],3.71667,51.05,{"lat":377,"lon":376},{"facility":380,"status":37,"city":381,"state":382,"zip":383,"country":352,"countryCode":353,"cosmosGeoPoint":384,"geoPoint":388,"contacts":37},"Universitair Ziekenhuis Leuven \u002FID# 226608","Leuven","Vlaams-Brabant","3000",{"type":67,"coordinates":385},[386,387],4.70093,50.87959,{"lat":387,"lon":386},{"facility":390,"status":37,"city":391,"state":37,"zip":392,"country":393,"countryCode":394,"cosmosGeoPoint":395,"geoPoint":399,"contacts":37},"Orszagos Koranyi Pulmonologiai Intezet \u002FID# 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AA",{"type":67,"coordinates":426},[427,428],4.29861,52.07667,{"lat":428,"lon":427},{"facility":431,"status":37,"city":432,"state":433,"zip":434,"country":435,"countryCode":436,"cosmosGeoPoint":437,"geoPoint":441,"contacts":37},"Greenlane Clinical Centre \u002FID# 227282","Epsom","Auckland","1051","New Zealand","NZ",{"type":67,"coordinates":438},[439,440],174.77059,-36.88745,{"lat":440,"lon":439},{"facility":443,"status":37,"city":444,"state":445,"zip":446,"country":435,"countryCode":436,"cosmosGeoPoint":447,"geoPoint":451,"contacts":37},"Christchurch Hospital \u002FID# 227335","Christchurch","Canterbury","8011",{"type":67,"coordinates":448},[449,450],172.63333,-43.53333,{"lat":450,"lon":449},{"facility":453,"status":37,"city":454,"state":37,"zip":455,"country":456,"countryCode":457,"cosmosGeoPoint":458,"geoPoint":462,"contacts":37},"Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica \u002FID# 228044","Banská Bystrica","975 17","Slovakia","SK",{"type":67,"coordinates":459},[460,461],19.14932,48.73947,{"lat":461,"lon":460},{"facility":464,"status":37,"city":465,"state":37,"zip":466,"country":456,"countryCode":457,"cosmosGeoPoint":467,"geoPoint":471,"contacts":37},"Univerzitna nemocnica Bratislava Nemocnica Ruzinov \u002FID# 228042","Bratislava","821 06",{"type":67,"coordinates":468},[469,470],17.10674,48.14816,{"lat":470,"lon":469},{"type":473,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100428003","phase-2-study-to-evaluate-adverse-events-and-change-in-disease-activity-with-oral-capsules-of-galicaftornavocaftorabbv-119-or-galicaftornavocaftorabbv-576-combination-therapies-in-adult-participants-with-cystic-fibrosis-100428003",true,"NCT04853368","Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor\u002FNavocaftor\u002FABBV-119 or Galicaftor\u002FNavocaftor\u002FABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis","A Phase 2 Study of Galicaftor\u002FNavocaftor\u002FABBV-119 or Galicaftor\u002FNavocaftor\u002FABBV-576 Combination Therapies in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation","Inclusion Criteria:\n\n* Confirmed clinical diagnosis of cystic fibrosis (CF).\n* Arm 1 participants with genotype homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation and not receiving elexacaftor\u002Ftezacaftor\u002Fivacaftor (ETI) treatment .\n* Arm 2 and 3 participants with genotype heterozygous for the F508del CFTR mutation and a minimal function mutation and not receiving ETI treatment.\n* Arm 4 participants with genotype either homozygous or heterozygous for the F508del mutation. Participants must be receiving stable ETI treatment.\n* Percent predicted forced expiratory volume in 1 second (ppFEV1) \\>= 40% and \\\u003C=90% of predicted normal for age, gender and height at screening.\n* For arms 1 and 2: sweat chloride (SwCl) \\>= 60 mmol\u002FL at screening. For participants who participated in Study M19-530, it is acceptable to use a SwCl value that the central lab provided in Study M19-530 to establish eligibility.\n* Weight \\>= 35 kg at screening and Day -28 for arm 1 or day 1 for arms 2 to 4.\n\nExclusion Criteria:\n\n\\- Clinically significant laboratory values at screening that would pose undue risk for the participant or interfere with safety assessments (per the investigator).",false,"ALL","18 Years",{"count":485,"type":486},48,"ACTUAL","INTERVENTIONAL",[489],"PHASE2","Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The main objective of this study is to assess how safe and effective is the combination therapy of galicaftor\u002Fnavocaftor\u002FABBV-119 or Galicaftor\u002FNavocaftor\u002FABBV-576 in adult participants with CF who are homozygous or heterozygous for the F508del mutation in each arm.\n\nGalicaftor\u002FNavocaftor\u002FABBV-119 combination therapy and Galicaftor\u002FNavocaftor\u002FABBV-576 is being developed as an investigational drug for the treatment of CF. Study doctors place participants in 1 of the 4 groups, called treatment arms. Each group receives a different treatment. Around 90 adult participants with a diagnosis of CF will be enrolled in the study around approximately 35 sites worldwide.\n\nParticipants in arm 1 will receive oral capsules of galicaftor\u002Fnavocaftor dual combination for 28 days followed by galicaftor\u002Fnavocaftor\u002FABBV-119 triple combination for 28 days. Participants in arms 2 and 3 will receive the galicaftor\u002Fnavocaftor\u002FABBV-119 triple combination or placebo for 28 days. Participants in arm 4 will receive galicaftor\u002Fnavocaftor\u002FABBV-576 triple combination therapy for 28 days. For all study arms, ABBV-576, galicaftor, navocaftor, will be given once daily and ABBV-119 twice a day.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[492],"Cystic Fibrosis (CF)",[492,39,47,52,34],"TERMINATED","Strategic considerations","2024-07-15",{"date":498,"type":486},"2024-07-16",{"date":500,"type":486},"2021-09-20",{"date":502,"type":486},"2023-06-05",{"name":5,"class":6},41]