Informations générales (source: ClinicalTrials.gov)

NCT05444257 Active, sans recrutement
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
  • Mucoviscidose
  • Fibrose
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 Active, sans recrutement 25/11/2024 08:06:24  Contacter
CHI DE CRETEIL Ralph EPAUD Active, sans recrutement 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


- 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.