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VX18-445-110 VX-445/TEZ/IVA Open-label in CF (F/G and F/RF)

  • Research type

    Research Study

  • Full title

    A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

  • IRAS ID

    268821

  • Contact name

    Peter Barry

  • Contact email

    Peter.Barry@MFT.NHS.UK

  • Eudract number

    2019-000833-37

  • Duration of Study in the UK

    2 years, 8 months, 29 days

  • Research summary

    Cystic fibrosis (CF) is a lifelong disease resulting from changes (mutations) in the code for one gene called the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Changes in this gene can affect the amount of the protein made from this gene or how well the protein works. When there is not enough protein or it does not work properly, some fluids in the body become sticky and causes problems in the lungs and other organs. VX-445, tezacaftor and ivacaftor are a triple combination of therapies targeted at improving the function of this protein. Early studies have suggested that this triple combination may improve health in some patients with CF. This clinical trial will evaluate how well the triple combination may treat CF in men and women with CF who are 12 years or older, and who have certain mutations in their CF genes. This study will test the triple combination in people with one copy of a CF gene with a mutation termed F508del and the other copy of a CF gene with a mutation termed a gating or residual function.
    The study will include participants from study VX18-445-104 and all participants will receive active treatment (triple combination of VX-445, tezacaftor and ivacaftor). The study duration is 100 weeks, which includes up to 96 weeks of treatment and a follow-up visit after 4 weeks. The study will check if the triple combination can improve lung function and other measures of health in people with cystic fibrosis.

  • REC name

    London - Westminster Research Ethics Committee

  • REC reference

    19/LO/1317

  • Date of REC Opinion

    29 Oct 2019

  • REC opinion

    Further Information Favourable Opinion