Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age
← catalyst calendarSponsored by Vertex Pharmaceuticals Incorporated (industry) · VRTX — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
70actual
Sites
19
Countries
Australia, Canada, Denmark +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-06-27 | actual | When the study began enrolling |
| Primary completion | 2025-09-04 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-04 | actual | The whole study's end, after follow-up |
| First posted | 2023-05-31 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Cystic Fibrosis
Interventions
- Drug: ELX/TEZ/IVA — also filed as VX-445/VX-661/VX-770, elexacaftor/tezacaftor/ivacaftor
- Drug: IVA — also filed as VX-770, ivacaftor
Primary outcomes
what the primary-completion date above is the date OFPart A: Observed Pre-dose Concentration (Ctrough) of ELX, TEZ, IVA, and their Relevant Metabolites
measured Day 1 up to Day 15
Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured Day 1 up to Day 43
Part B: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured Day 1 up to Week 28
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