Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 Years
Completed · Phase 3
Conditions studied: Cystic Fibrosis
In brief
This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination therapy in CF subjects 2 through 5 years of age.
Key facts
- Study ID
- NCT04537793
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 83
- Starts
- 2020-11-19
- Expected to finish
- 2022-06-03
- Last updated by the study team
- 2023-06-28
Who can join
Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Banner University of Arizona Medical Center — Tucson, Arizona, United States
- Stanford University — Palo Alto, California, United States
- Children's Hospital of Colorado — Aurora, Colorado, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
- The Children's Mercy Hospital — Kansas City, Missouri, United States
- Washington University School of Medicine / St. Louis Children's Hospital — St Louis, Missouri, United States
- NC TraCS Institute - CTRC University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Oregon Health & Science University — Portland, Oregon, United States
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- Telethon Kids Institute — Nedlands, Australia
- The Royal Children's Hospital — Parkville, VIC, Australia
- Queensland Children's Hospital — South Brisbane, Australia
- The Hospital for Sick Children — Toronto, Canada
- British Columbia Children's Hospital — Vancouver, Canada
- Charite Paediatric Pulmonology Department — Berlin, Germany
- Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie — Essen, Germany
- Alder Hey Children's NHS Foundation Trust — Liverpool, United Kingdom
- Royal Brompton Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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