Trial Profile

A Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 20 Aug 2021

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At a glance

Drugs Elexacaftor/ivacaftor/tezacaftor (Primary) ; Ivacaftor; Ivacaftor/tezacaftor
Indications Cystic fibrosis
Focus Registrational; Therapeutic Use
Sponsors Vertex Pharmaceuticals

Most Recent Events

20 May 2021 Outcomes of a validated, lifetime, patient-level simulation model build using data from the IVA/TEZ/ELX Phase 3b study (NCT04105972) and TEZ/IVA Phase 3 study (NCT02347657), were presented at the 26th Annual
21 Aug 2020 Status changed from active, no longer recruiting to completed.
04 Mar 2020 Status changed from recruiting to active, no longer recruiting.

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