drugset / Trial / NCT05882357

Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age

NCT05882357 ↗

Phase 3 Completed 70 enrolled Vertex Pharmaceuticals Incorporated
Non-randomizedSequentialOpen-labelTreatment

Summary

This study will evaluate the pharmacokinetics (PK), safety, tolerability, pharmacodynamics (PD), and efficacy of ELX/TEZ/IVA in CF subjects 12 to less than (\<) 24 months of age.

Timeline

Start
2023-06-27
Primary completion
2025-09-04
Completion
2025-09-04

Drugs

EvaluationDrugModalityDoseRoute
Subject ELX/TEZ/IVA Unknown — Oral
Subject IVA Unknown — Oral

Indications