Evaluation of long term safety and efficacy of ELX/TEZ/IVA in Cystic Fibrosis Subjects 12 Months of

• Research type

  Research Study

• Full title

  A Phase 3, Open-label Study Evaluating the Long‑term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 Months of Age and Older.

• IRAS ID

  1010177

• Contact name

  Sabrina Caiafa

• Contact email

  sitesf1rst_uk@vrtx.com

• Sponsor organisation

  Vertex Pharmaceuticals Incorporated

• Clinicaltrials.gov Identifier

  NCT06460506

• Research summary

  VX22-445-123 is a study being conducted at multiple Cystic Fibrosis (CF) centers to evaluate the long-term safety, tolerability, pharmacodynamics (PD) and effectiveness of ELX/TEZ/IVA in CF subjects 12 months of age and older. Approximately 50 subjects who previously participated in VX22-445-123 will be given ELX/TEZ/IVA for 96 weeks. Participants will be monitored closely during the study to assess for the safety and effectiveness of ELX/TEZ/IVA.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  24/LO/0784

• Date of REC Opinion

  14 Nov 2024

• REC opinion

  Further Information Favourable Opinion