VX17-445-103 Efficacy and Safety of VX-445/TEZ/IVA in CF Homozygous
- Therapeutic category
- Restore CFTR Function
- Trial status
- Closed to recruitment - in follow up Participating Centres
- Phase III
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
- Trial type
- VX-445 in triple combination with tezacaftor and ivacaftor.
- Recruitment target
- Last edited date
- CF sponsor
- Vertex Pharmaceuticals Incorporated
- CF sponsor type
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.