Informations générales (source: ClinicalTrials.gov)
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis
Interventional
Phase 3
Vertex Pharmaceuticals Incorporated (Voir sur ClinicalTrials)
novembre 2022
octobre 2026
14 août 2024
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy
of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic
fibrosis.
Etablissements
Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
---|---|---|---|---|---|
AP-HP - Hôpital Cochin | DOMINIQUE GRENET | 25/11/2024 08:06:24 | Contacter | ||
CHI DE CRETEIL | Ralph EPAUD | 29/03/2024 01:30:16 | 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 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-Benite - France | Contact (sur clinicalTrials) | ||||
Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur - Nice - France | Contact (sur clinicalTrials) | ||||
CHU de Rouen - Hopital Charles Nicolle - Rouen - France | Contact (sur clinicalTrials) | ||||
CHU Lyon - Hopital Femme Mere-Enfant - Bron Cedex - France | Contact (sur clinicalTrials) | ||||
Groupe Hospitaler Pellegrin, CHU De Bordeaux - Bordeaux cedex - France | Contact (sur clinicalTrials) | ||||
Hopital Arnaud de Villeneuve - Montpellier Cedex 5 - France | Contact (sur clinicalTrials) | ||||
Hopital Bretonneau - Tours - France | Contact (sur clinicalTrials) | ||||
Hôpital de Hautepierre, AX5 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
Hopital Foch (Suresnes), Hopital Foch, Adultes - Suresnes - 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 a parent study VX20-121-102 (NCT05033080)
and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study
but did not permanently discontinue study drug, and 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 did not permanently discontinue study drug, and completed study
visits up to the last scheduled visit of the Treatment Period of Part A
Key
- Part A: Completed study drug treatment in a parent study VX20-121-102 (NCT05033080)
and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study
but did not permanently discontinue study drug, and 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 did not permanently discontinue study drug, and completed study
visits up to the last scheduled visit of the Treatment Period of Part A
Key
- History of drug intolerance in a parent study
- Pregnant or breast-feeding females at the time of enrollment in Part A
Other protocol defined Inclusion/Exclusion criteria may apply.