Trial Profile
A Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 07 Nov 2021
Price :
$35
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At a glance
- Drugs Ivacaftor (Primary)
- Indications Cystic fibrosis
- Focus Registrational; Therapeutic Use
- Acronyms KONNECTION
- Sponsors Vertex Pharmaceuticals
- 30 Jul 2014 According to a Vertex Pharmaceuticals media release, CHMP has given positive opinion for approval of ivacftor in treating cystic fibrosis in patients of who have one of the 8 non-G551D gating mutations.
- 27 Jun 2014 Results (part two of the trial) presented at the European Cystic Fibrosis Society Conference in June 2014.
- 27 Jun 2014 Results (Part one of the trial) published in the Vertex Pharmaceuticals Media Release.