Cystic Fibrosis

Study Outline

This clinical trial is a Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects.

The study aims to evaluate the safety and tolerability of VX-445 (elexacaftor)/tezacaftor/ivacaftor in Cystic Fibrosis patients homozygous for F508del (F/F).

To find out if this trial is suitable for you please register below or contact our Clinical Trials Team at admin@resphealth.uwa.edu.au or phone 6151 0888.

Eligibility & Requirements

• Aged 18 or over with a diagnosis of Cystic Fibrosis and an F/F genotype.
• Completed the parent study VX18-445-109.
• Not pregnant or breastfeeding.

What's Involved

• The total study duration is approximately 52 weeks (from the first dose of study drug), including a Treatment Period of 48 weeks and a 4-week Safety Follow-up Visit.
• It involves up to 8 visits to the Institute for Respiratory Health at the QEII Medical Centre in Nedlands and up to 7 phone calls.