A Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del (VX18-445-109)

Details

Therapeutic category
Restore CFTR Function
Trial status
Closed to recruitment - in follow up Participating Centres
Phase
Phase III

Full title

A Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/ Tezacaftor / Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del

A Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
Trial Reference Number
124012
Trial type
Medication
Intervention
CFTR Modulators
Recruitment target
158
Last edited date
08/11/2019
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Top inclusion criteria
  • 12 Years and older
  • Homozygous for the F508del mutation
  • FEV1 value ≥40% and ≤90%
Top exclusion criteria
  • Clinically significant cirrhosis with or without portal hypertension.
  • Lung infection

Your donation will make a difference:

Select amount