{ "data": { "asOf": "2026-10-30T22:26:37.028Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT05331183", "title": "Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del", "scientificTitle": "A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes", "status": "active", "studyType": "interventional", "phase": [ "PHASE3" ], "conditions": [ "Cystic Fibrosis" ], "interventions": [ { "name": "ELX/TEZ/IVA", "type": "DRUG", "description": "Fixed-dose combination (FDC) tablets for oral administration." }, { "name": "IVA", "type": "DRUG", "description": "Tablets for oral administration." } ], "sponsor": { "name": "Vertex Pharmaceuticals Incorporated", "type": "INDUSTRY" }, "locations": [ { "city": "Innsbruck", "country": "Austria", "facility": "Medizinische Universität Innsbruck - Heilstättenschule Universitätsklinik" }, { "city": "Brussels", "country": "Belgium", "facility": "CUB Hôpital Erasme" }, { "city": "Brussels", "country": "Belgium", "facility": "UZ Brussel - Campus Jette" }, { "city": "Edegem", "country": "Belgium", "facility": "Universitair Ziekenhuis Antwerpen (UZA) - Antwerp University Hospital" }, { "city": "Ghent", "country": "Belgium", "facility": "Universitair Ziekenhuis Gent" }, { "city": "Leuven", "country": "Belgium", "facility": "Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg" }, { "city": "Woluwe-Saint-Lambert", "country": "Belgium", "facility": "Universite Catholique de Louvain - Pulmonology" }, { "city": "Edmonton", "country": "Canada", "facility": "Stollery Children's Hospital" }, { "city": "Montreal", "country": "Canada", "facility": "Le Centre de recherche du CHUM (CRCHUM)" }, { "city": "Montreal", "country": "Canada", "facility": "McGill University Health Centre, Glen Site, Montreal Children's Hospital" }, { "city": "Toronto", "country": "Canada", "facility": "Hospital for Sick Children - Pulmonology" }, { "city": "Vancouver", "country": "Canada", "facility": "British Columbia Children's Hospital" }, { "city": "Vancouver", "country": "Canada", "facility": "St. Paul's Hospital - Pulmonology" }, { "city": "Brno", "country": "Czechia", "facility": "Klinika Detskych Infekcnich Nemoci" }, { "city": "Prague", "country": "Czechia", "facility": "Motol University Hospital" }, { "city": "Bron", "country": "France", "facility": "Hopital Femme Mere-Enfant" }, { "city": "Créteil", "country": "France", "facility": "Centre Hospitalier Intercommunal Creteil - Pulmonology" }, { "city": "Lille", "country": "France", "facility": "Institut Cœur Poumon, CHU de Lille" }, { "city": "Marseille", "country": "France", "facility": "Hopital Nord" }, { "city": "Montpellier", "country": "France", "facility": "Hopital Arnaud de Villeneuve - Service de Pneumologie et Maladies Respiratoires" }, { "city": "Nantes", "country": "France", "facility": "Hôpital Nord Laennec" }, { "city": "Nice", "country": "France", "facility": "CHU de Nice - Hôpital Pasteur 2" }, { "city": "Paris", "country": "France", "facility": "Hopital Cochin - Pulmonology" }, { "city": "Paris", "country": "France", "facility": "Hopital Necker Enfants Malades - Pulmonology" }, { "city": "Paris", "country": "France", "facility": "Hopital Robert Debre - Pulmonology" }, { "city": "Pierre-Bénite", "country": "France", "facility": "Hôpital Lyon Sud - Pulmonology" }, { "city": "Reims", "country": "France", "facility": "Hôpital américain de Reims - Département de pédiatrie A" }, { "city": "Rennes", "country": "France", "facility": "Hôpital Sud - Rennes" }, { "city": "Roscoff", "country": "France", "facility": "Centre de Perharidy, Roscoff" }, { "city": "Toulouse", "country": "France", "facility": "Hopital Larrey" }, { "city": "Tours", "country": "France", "facility": "Hopital Bretonneau" }, { "city": "Berlin", "country": "Germany", "facility": "Charité - Paediatric Pulmonology Department" }, { "city": "Cologne", "country": "Germany", "facility": "University Hospital Cologne (Koeln) - CF-Studienzentrum" }, { "city": "Essen", "country": "Germany", "facility": "Ruhrlandklinik" }, { "city": "Frankfurt", "country": "Germany", "facility": "Klinikum der Johann-Wolfgang-Goethe Universitaet - Pulmonology" }, { "city": "Giessen", "country": "Germany", "facility": "Justus-Liebig-Universität Gießen" }, { "city": "Halle", "country": "Germany", "facility": "Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie" }, { "city": "Hanover", "country": "Germany", "facility": "Medizinische Hochschule Hannover - Clinic for Pediatric Pneumology, Allergology and Neonatology, CF-Centre" }, { "city": "Hanover", "country": "Germany", "facility": "Medizinische Hochschule Hannover" }, { "city": "Jena", "country": "Germany", "facility": "Mukoviszidose-Zentrum am Universitätsklinikum Jena" }, { "city": "Mainz", "country": "Germany", "facility": "Johannes Gutenberg-Universitaet" }, { "city": "München", "country": "Germany", "facility": "Dr. von Haunersches Kinderspital - Pulmonology" }, { "city": "München", "country": "Germany", "facility": "Lungenheilkunde Munchen - Pasing" }, { "city": "Münster", "country": "Germany", "facility": "Klinik für Kinder- und Jugendmedizin" }, { "city": "Potsdam", "country": "Germany", "facility": "Klinikum Westbrandenburg (CF)" }, { "city": "Budapest", "country": "Hungary", "facility": "National Koranyi Institute for TBC and Pulmonology" }, { "city": "Ancona", "country": "Italy", "facility": "Azienda Ospedaliero Universitaria delle Marche" }, { "city": "Florence", "country": "Italy", "facility": "Azienda Ospedaliero Universitaria Ospedale Meyer" }, { "city": "Genova", "country": "Italy", "facility": "IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico" }, { "city": "Messina", "country": "Italy", "facility": "Policlinico Universitario G. Martino" }, { "city": "Milan", "country": "Italy", "facility": "Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena" }, { "city": "Milan", "country": "Italy", "facility": "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico" }, { "city": "Naples", "country": "Italy", "facility": "Azienda Ospedaliero Universitaria Federico II Napoli" }, { "city": "Orbassano", "country": "Italy", "facility": "Azienda Ospedaliero Universitaria (AOU) San Luigi Gonzaga" }, { "city": "Potenza", "country": "Italy", "facility": "Azienda Ospedaliera Regionale 'San Carlo', Potenza" }, { "city": "Rome", "country": "Italy", "facility": "IRCSS Ospedale Pediatrico Bambino Gesu - Pulmonology" }, { "city": "Verona", "country": "Italy", "facility": "Azienda Ospedaliera di Verona - Ospedale Civile Maggiore" }, { "city": "Amsterdam", "country": "Netherlands", "facility": "Amsterdam UMC - locatie AMC - Afdeling Longgeneeskunde" }, { "city": "Nijmegen", "country": "Netherlands", "facility": "Radboud University Medical Center - Pulmonology" }, { "city": "Rotterdam", "country": "Netherlands", "facility": "Erasmus Medisch Centrum - Pulmonology" }, { "city": "The Hague", "country": "Netherlands", "facility": "HagaZiekenhuis" }, { "city": "Utrecht", "country": "Netherlands", "facility": "UMCU, Locatie Wilhelmina Kinderziekenhuis" }, { "city": "Oslo", "country": "Norway", "facility": "Oslo University Hospital, Department of Paediatric Medicine" }, { "city": "Gdansk", "country": "Poland", "facility": "Pediatric Hospital Polanki named of Maciej Płażyński" }, { "city": "Łomianki", "country": "Poland", "facility": "Instytut Matki i Dziecka, Klinika Mukowiscydozy IMiD, Oddział Chorób Płuc SZPZOZ im.Dzieci Warszawy w Dziekanowie Leśnym" }, { "city": "Lisbon", "country": "Portugal", "facility": "Unidade Local de Saúde de Santa Maria, E.P.E. - Pulmonology" }, { "city": "Barakaldo", "country": "Spain", "facility": "Hospital de Cruces" }, { "city": "Barcelona", "country": "Spain", "facility": "Hospital Saint Joan de Deu" }, { "city": "Barcelona", "country": "Spain", "facility": "Hospital Universitari Vall d´Hebron Servicio de Broncoscopia" }, { "city": "Jerez de la Frontera", "country": "Spain", "facility": "Hospital Universitario de Jerez de la Frontera" }, { "city": "Madrid", "country": "Spain", "facility": "Hospital Infantil Universitario Nino Jesus" }, { "city": "Madrid", "country": "Spain", "facility": "Hospital Universitario 12 de Octubre - Pulmonology" }, { "city": "Madrid", "country": "Spain", "facility": "Hospital Universitario Ramon y Cajal - Pulmonology" }, { "city": "Madrid", "country": "Spain", "facility": "La Paz Infantil" }, { "city": "Murcia", "country": "Spain", "facility": "Hospital Virgen de la Arrixaca" }, { "city": "Sabadell", "country": "Spain", "facility": "Institut d´Investigacio i Innovacio Parc Tauli" }, { "city": "Seville", "country": "Spain", "facility": "Hospital Universitario Virgen del Rocio" }, { "city": "Valencia", "country": "Spain", "facility": "Hospital Universitario y Politecnico La Fe - Pulmonology" }, { "city": "Gothenburg", "country": "Sweden", "facility": "Sahlgrenska Universitetssjukhuset - Göteborg CF-center" }, { "city": "Stockholm", "country": "Sweden", "facility": "Karolinska University Hospital - Pulmonology" }, { "city": "Zurich", "country": "Switzerland", "facility": "Kinderspital Zuerich" } ], "outcomes": { "other": [], "primary": [ "Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)" ], "secondary": [ "Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)", "Part A: Absolute Change in Sweat Chloride (SwCl)", "Part A: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain (RD) Score", "Part A: Absolute Change in Body Mass Index (BMI)", "Part A: Absolute Change in Weight", "Part A: Number of Pulmonary Exacerbations (PEx)" ] }, "eligibility": { "sex": "ALL", "criteria": "Key Inclusion Criteria:\n\nPart A: Completed study drug treatment in parent study or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study\n\nPart B: Completed study drug treatment in Part A or had study drug interruption(s) in Part A but completed study visits up to the last scheduled visit of the treatment period of Part A\n\nKey Exclusion Criteria:\n\nHistory of study drug intolerance in the parent study\n\nOther protocol defined Inclusion/Exclusion criteria may apply.", "minimumAge": "6 Years", "healthyVolunteers": false }, "enrollment": { "type": "ACTUAL", "count": 297 }, "startDate": "2022-11-23", "completionDate": "2027-04-06", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2022-04-15T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT05331183" ] }, "identifiers": [ { "idType": "euct", "idValue": "2024-515637-14-00", "declaredBy": "clinicaltrials_gov" }, { "idType": "eudract", "idValue": "2021-005914-33", "declaredBy": "clinicaltrials_gov" }, { "idType": "nct", "idValue": "NCT05331183", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT05331183", "sourceUrl": "https://clinicaltrials.gov/study/NCT05331183", "sourceStatus": "ACTIVE_NOT_RECRUITING", "retrievedAt": "2026-10-28T04:32:26.116Z", "payloadSha256": "0c18a822ba1116fc724b9e9a5e42866efb335493837029b575401110cd9407e6", "piiRedacted": true } ], "citation": { "canonicalId": "NCT05331183", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT05331183", "verifyAt": "https://clinicaltrials.gov/study/NCT05331183", "retrievedAt": "2026-10-28T04:32:26.116Z", "payloadSha256": "0c18a822ba1116fc724b9e9a5e42866efb335493837029b575401110cd9407e6", "text": "ClinicalTrials.gov, record NCT05331183 (https://clinicaltrials.gov/study/NCT05331183), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT05331183, registered in ClinicalTrials.gov, retrieved 2026-10-28. Verify at the source URLs listed; each retrieval is checksummed.", "note": "Only one registry is known to hold this trial. Absence from the others is not evidence it was not registered there." }, "provenanceNote": "Personal contact fields (names, emails, phone numbers, addresses) are stripped from every stored payload. No participant-level data is collected or served." }, "_meta": { "api": "The Last Economy Wire: World Trials API", "version": "1.0", "schemaVersion": "1", "correlationId": "req_tNLQAT1xIbXN", "generatedAt": "2026-10-30T22:26:37.028Z", "documentation": "https://negativeresistance.com/embed", "license": "Free for any use. Attribution appreciated.", "degraded": false, "provenance": { "sources": [ "clinicaltrials_gov" ], "attribution": { "clinicaltrials_gov": "ClinicalTrials.gov: licence: public-domain, https://clinicaltrials.gov/data-api/api-docs" }, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "limitations": [], "provenanceEndpoint": "/api/v1/sources" }, "freshness": { "newestEvidenceAt": null, "lastSyncedAt": { "clinicaltrials_gov": "2026-10-28T04:33:30.663Z" }, "degradedSources": [], "worldwide": false, "maxAgeHours": 65.9, "fromCache": false }, "links": { "discovery": "https://negativeresistance.com/api/v1", "openapi": "https://negativeresistance.com/api/v1/openapi.json", "mcp": "https://negativeresistance.com/api/v1/mcp", "agentCard": "https://negativeresistance.com/.well-known/agent.json", "aiPlugin": "https://negativeresistance.com/.well-known/ai-plugin.json", "sdk": "https://negativeresistance.com/api/v1/sdk", "status": "https://negativeresistance.com/api/v1/status", "provenance": "https://negativeresistance.com/api/v1/sources", "contract": "https://negativeresistance.com/api/v1/contract", "curriculum": "https://negativeresistance.com/api/v1/curriculum", "graph": "https://negativeresistance.com/api/v1/graph", "openQuestions": "https://negativeresistance.com/api/v1/open-questions", "scoreboard": "https://negativeresistance.com/api/v1/scoreboard", "findings": "https://negativeresistance.com/api/v1/findings", "claims": "https://negativeresistance.com/api/v1/claims", "threads": "https://negativeresistance.com/api/v1/threads", "assignment": "https://negativeresistance.com/api/v1/assignment", "changes": "https://negativeresistance.com/api/v1/changes", "hello": "https://negativeresistance.com/api/v1/hello", "errors": "https://negativeresistance.com/api/v1/errors", "webhooks": "https://negativeresistance.com/api/v1/webhooks", "a2a": "https://negativeresistance.com/api/v1/a2a", "deadEnds": "https://negativeresistance.com/api/v1/dead-ends", "decompositions": "https://negativeresistance.com/api/v1/decompositions", "rungs": "https://negativeresistance.com/api/v1/rungs", "methods": "https://negativeresistance.com/api/v1/methods", "reality": "https://negativeresistance.com/api/v1/reality", "council": "https://negativeresistance.com/api/v1/council", "calibration": "https://negativeresistance.com/api/v1/calibration", "freshness": "https://negativeresistance.com/api/v1/freshness", "mission": "https://negativeresistance.com/api/v1/mission", "twin": "https://negativeresistance.com/api/v1/twin", "twinExperiment": "https://negativeresistance.com/api/v1/twin/experiment", "betaCell": "https://negativeresistance.com/api/v1/twin/beta-cell", "patientModel": "https://negativeresistance.com/api/v1/twin/patient-model", "agentCardCanonical": "https://negativeresistance.com/.well-known/agent-card.json", "collaborate": "https://negativeresistance.com/collaborate", "manifesto": "https://negativeresistance.com/about", "documentation": "https://negativeresistance.com/embed", "connect": "https://negativeresistance.com/connect", "llmsTxt": "https://negativeresistance.com/llms.txt", "llmsFullTxt": "https://negativeresistance.com/llms-full.txt" }, "disclaimer": "Research data from public registries and literature; not medical advice." } }