Intestinal Current Measurements (ICM) to Evaluate the Activation of Mutant CFTR in Subjects With Cystic Fibrosis Aged 12 Years and Older, Homozygous for the p.Phe508del-CFTR Mutation, Treated With Lumacaftor in Combination With Ivacaftor

Trial Profile

Intestinal Current Measurements (ICM) to Evaluate the Activation of Mutant CFTR in Subjects With Cystic Fibrosis Aged 12 Years and Older, Homozygous for the p.Phe508del-CFTR Mutation, Treated With Lumacaftor in Combination With Ivacaftor

Recruiting
Phase of Trial: Phase IV

Latest Information Update: 28 Feb 2018

At a glance

  • Drugs Ivacaftor/lumacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Biomarker; Pharmacodynamics
  • Acronyms OrkambiFacts
  • Most Recent Events

    • 26 Feb 2018 Planned number of patients changed from 125 to 100.
    • 12 Jan 2018 Results (n=53; till March 2017) assessing effect of lumacaftor -ivacaftor on biomarkers published in the American Journal of Respiratory and Critical Care Medicine.
    • 10 Jun 2017 Biomarkers information updated
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