Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Vertex Pharmaceuticals Incorporated (Voir sur ClinicalTrials)
novembre 2022
avril 2027
29 juin 2024
This study will evaluate the long-term safety, efficacy and pharmacodynamics of
ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del
ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Ralph EPAUD | 29/03/2024 01:30:06 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Necker-Enfants Malades | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Robert Debré | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Perharidy - Roscoff cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Lyon Sud - Pierre-Bénite - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire De Nantes - G. R. Laennec - Nantes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire De Reims, Hopital Sebastopol - Reims - France | Contact (sur clinicalTrials) | ||||
| CHU de Rennes - Hôpital Sud - Rennes - France | Contact (sur clinicalTrials) | ||||
| CHU de Toulouse - Hopital Larre - Toulouse - France | Contact (sur clinicalTrials) | ||||
| CHU Lyon - Hopital Femme Mere-Enfant - Bron Cedex - France | Contact (sur clinicalTrials) | ||||
| CHU Marseille - Hopital Nord - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hopital Arnaud de Villeneuve - Montpellier Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Hopital Bretonneau - Tours - France | Contact (sur clinicalTrials) | ||||
| Institut Cœur Poumon, CHU de Lille - Lille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Part 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
- Part 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
Key
- Part 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
- Part 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
Key
- History of study drug intolerance in the parent study
Other protocol defined Inclusion/Exclusion criteria may apply.