Trial Profile
A Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR 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) ; Ivacaftor/lumacaftor (Primary) ; Lumacaftor (Primary)
- Indications Cystic fibrosis
- Focus Adverse reactions; Pharmacokinetics; Registrational
- Sponsors Vertex Pharmaceuticals
- 10 Jan 2018 According to a Vertex Pharmaceuticals media release, based on the data from this and another phase III trial, the European Commission has granted extension of the Marketing Authorization for ORKAMBI (lumacaftor/ivacaftor), to treat the underlying cause of cystic fibrosis (CF) in people with two copies of the F508del mutation, to include children ages 6 through 11.
- 02 Nov 2016 Results of Part B assessing assessing safety and tolerability published in the American Journal of Respiratory and Critical Care Medicine
- 28 Sep 2016 Data from this trial will be presented at the 30th Annual North American Cystic Fibrosis Conference, as per Vertex media release.