Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Completed · Phase 3
Conditions studied: Cystic Fibrosis
In brief
This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF genotypes.
Key facts
- Study ID
- NCT03691779
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 71
- Starts
- 2018-10-02
- Expected to finish
- 2020-08-07
- Last updated by the study team
- 2021-10-22
Who can join
Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital of Orange County — Orange, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Ann & Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, 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
- Northwell Health- Long Island Jewish Medical Center — New Hyde Park, New York, United States
- Clinical Research of Charlotte — Charlotte, North Carolina, United States
- Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Texas Children's Hospital — Houston, Texas, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- Queensland Children's Hospital — South Brisbane, Australia
- The Children's Hospital at Westmead — Westmead, Australia
- The Hospital for Sick Children — Toronto, Canada
- British Columbia's Children's Hospital — Vancouver, Canada
- Children's Health Ireland at Crumlin — Dublin, Ireland
- Children's Health Ireland at Temple Street — Dublin, Ireland
- Birmingham Children's Hospital — Birmingham, United Kingdom
- Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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