VX17-445-103 Efficacy and Safety of VX-445/TEZ/IVA in CF Homozygous

Details

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

Full title

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)

To evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and VX-561 (deuterated ivacaftor, also known as CTP-656) in subjects with cystic fibrosis (CF)who are homozygous for the F508del mutation (F/F)
Trial Reference Number
106571
Trial type
Medication
Intervention
VX-445 in triple combination with tezacaftor and ivacaftor.
Recruitment target
100
Last edited date
10/09/2018
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Top exclusion criteria
  • Clinically significant cirrhosis with or without portal hypertension.
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Lung infection with organisms associated with a more rapid decline in pulmonary status.

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