A Phase 2, Multicenter, Double-Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Phase of Trial: Phase II
Latest Information Update: 20 Sep 2017
At a glance
- Drugs Ivacaftor (Primary) ; Tezacaftor (Primary)
- Indications Cystic fibrosis
- Focus Adverse reactions; Pharmacodynamics; Proof of concept
- Sponsors Vertex Pharmaceuticals
- 20 Sep 2017 Results (n=190) assessing safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of VX-661 alone or in combination with ivacaftor (VX-770) for the treatment of patients with cystic fibrosis and either a homozygous or heterozygous F508del-CFTR mutation, were published in the American Journal of Respiratory and Critical Care Medicine
- 07 Apr 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
- 25 Oct 2013 Planned End Date changed from 1 Aug 2013 to 1 Mar 2014 as reported by ClinicalTrials.gov.