A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

 Cystic Fibrosis / Posted 2 years ago

This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

  • Inclusion Criteria :
    • Subject has a confirmed diagnosis of CF and is heterozygous for F508del and either a gating or residual function mutation (F/G and F/RF genotypes)
    • Forced expiratory volume in 1 second (FEV1) value 40% to 50% of predicted mean for age, sex, and height
  • Exclusion Criteria :
    • Clinically significant cirrhosis with or without portal hypertension
    • Lung infection with organisms associated with a more rapid decline in pulmonary status
    • Solid organ or hematological transplantation
  • Study start date : 01/08/2019
  • Study end date : 01/10/2020
  • Wales-Based Study Contact : please speak to your clinician

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