VX22-121-106

• Research type

  Research Study

• Full title

  A Phase 3, Open-label Study Evaluating the Long‑term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Year of Age and Older

• IRAS ID

  1007411

• Contact name

  N/A N/A

• Contact email

  medicalinfo@vrtx.com

• Sponsor organisation

  Vertex Pharmaceuticals Incorporated

• Research summary

  The study is an open-label extension for the parent study VX21-121-105 (Ridgeline Study - Cohort B1) for children with cystic fibrosis. The participants in the original parent study were aged 6-11 years at recruitment, and each person in the study took the study medicine (vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA)) for 6 months. This new study will follow these same participants up for a further 100 weeks (hence why it’s called an ‘extension’ study). It allows the participants to continue receiving the study medicine, and for further information to be collected about safety and how well the drug works with longer term use.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  23/SW/0037

• Date of REC Opinion

  15 Aug 2023

• REC opinion

  Further Information Favourable Opinion