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ELX/TEZ/IVA in Cystic Fibrosis Subjects 12 to <24 Months of Age
NCT05882357Phase 3Completed
- Sponsor
- Vertex Pharmaceuticals
- Start
- Jun 2023
- Primary completion
- Sep 2025
- Modality
- Small Molecules
- Countries
- 7
01
Overview
Phase 3, open-label trial of elexacaftor, tezacaftor and ivacaftor in cystic fibrosis (CF) (2 arms), sponsored by Vertex Pharmaceuticals. Primary endpoints: Observed Pre-dose Concentration (Ctrough) of ELX, TEZ, IVA, and Their Relevant Metabolites at Day 15 and Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). Started Jun 2023; status: completed.
02
Drugs
elexacaftortezacaftorivacaftor
03
Conditions
cystic fibrosis (CF)
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