Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Trial Profile

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2019

At a glance

  • Drugs Ivacaftor/tezacaftor/VX-445 (Primary) ; Ivacaftor
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 03 Dec 2018 Status changed from recruiting to active, no longer recruiting.
    • 06 Sep 2018 According to a Vertex Pharmaceuticals media release, additional safety and efficacy data, including secondary endpoints followed by the completion of the study is expected in the second half of 2019.
    • 06 Sep 2018 According to a Vertex Pharmaceuticals media release, based on the primary efficacy endpoint at week 4 and the 12 week safety data of this study, the company expects to submit a NDA application to the US FDA for the VX-445, tezacaftor and ivacaftor triple combination regimen in people with one F508del mutation and one minimal function mutation before mid-2019.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top