A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Completed · Phase 3 · Has a placebo group
Conditions studied: Cystic Fibrosis
In brief
This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).
Key facts
- Study ID
- NCT03447249
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 385
- Starts
- 2018-03-07
- Expected to finish
- 2019-02-05
- Last updated by the study team
- 2020-03-13
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Stanford University — Palo Alto, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Hartford Health — Hartford, Connecticut, United States
- Yale New Haven Medical Center — New Haven, Connecticut, United States
- University of Miami/ Miller School of Medicine — Miami, Florida, United States
- Nicklaus Children's Hospital — Miami, Florida, United States
- Arnold Palmer Hospital — Orlando, Florida, United States
- Johns Hopkins All Children's Hospital Outpatient Care Center — St. Petersburg, Florida, United States
- St. Luke's CF Center of Idaho — Boise, Idaho, United States
- Cystic Fibrosis Center of Chicago — Glenview, Illinois, United States
- Advocate Children's Hospital - Park Ridge/ North Suburban Pulmonary and Critical Care Consultants — Niles, Illinois, United States
- Indiana Clinical Research Center, IU Health University Hospital — Indianapolis, Indiana, United States
- The University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- Kentucky Clinic — Lexington, Kentucky, United States
- Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
- The Johns Hopkins Hospital — Baltimore, Maryland, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
- University of Michigan Health System — Ann Arbor, Michigan, United States
- Helen DeVos Children's Hospital CF Center — Grand Rapids, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- University of Mississippi Medical Center — Jackson, Mississippi, United States
- Children's Mercy Hospital — Kansas City, Missouri, United States
- Washington University School of Medicine/ St. Louis Children's Hospital — St Louis, Missouri, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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