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)

Next Previous
X
Search
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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2022

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

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

    • Most Recent Events

    • 18 May 2022 Results by deriving clinical efficacy inputs were derived from NCT03691779, NCT03525444; estimating survival in Brazilian F/MF pwCF aged 6 years receiving ELX/TEZ/IVA+best supportive care (BSC) versus BSC-alone, presented at the 27th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
    • 18 Jun 2021 According to a Vertex Pharmaceuticals media release, Health Canada has granted Marketing Authorization for TRIKAFTA for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation.This approval was supported by positive results of three global Phase 3 studies (Study 445-102, Study 445-103 and Study 445-104).
    • 20 May 2021 Results of simulation model to determine survival data in F508del and a minimal function mutation population by using data from this study presented at the 26th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top