A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
Completed · Phase 3
Conditions studied: Cystic Fibrosis
In brief
This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).
Key facts
- Study ID
- NCT04058353
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 271
- Starts
- 2019-08-28
- Expected to finish
- 2020-06-12
- Last updated by the study team
- 2021-07-02
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Banner University of Arizona Medical Center — Tucson, Arizona, United States
- Miller Children's Hospital / Long Beach Memorial — Long Beach, California, United States
- Stanford University — Palo Alto, California, United States
- University of California Davis Medical Center — Sacramento, California, United States
- University of California San Francisco, Lung Transplant Program — San Francisco, California, United States
- National Jewish Health — Denver, Colorado, United States
- University of Miami Miller School of Medicine — Miami, Florida, United States
- Central Florida Pulmonary Group, PA — Orlando, Florida, United States
- Indiana University — Indianapolis, Indiana, United States
- The University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- University of Kentucky — Lexington, Kentucky, United States
- Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center — Boston, Massachusetts, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Michigan Medicine — Ann Arbor, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Washington University School of Medicine / St. Louis Children's Hospital — St Louis, Missouri, United States
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Northwell Health- Long Island Jewish Medical Center — New Hyde Park, New York, United States
- Mount Sinai Beth Israel — New York, New York, United States
- Columbia University Medical Center — New York, New York, United States
- University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
- UC Health Holmes — Cincinnati, Ohio, United States
- Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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