A Phase 3 Study of VX-445 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-445 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
- NCT03525444
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 405
- Starts
- 2018-06-15
- Expected to finish
- 2019-04-24
- Last updated by the study team
- 2020-05-19
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Miller Children's Hospital/ Long Beach Memorial — Long Beach, California, United States
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Valley Children's Hospital/ Children's Hospital of Central California — Madera, California, United States
- Kaiser Permanente — Oakland, California, United States
- University of California Davis Medical Center — Sacramento, California, United States
- UCSF Gateway Medical Center — San Francisco, California, United States
- National Jewish Health — Denver, Colorado, United States
- University of Florida, Shands Hospital — Gainesville, Florida, United States
- Joe DiMaggio Cystic Fibrosis & Pulmonary Center/ Joe DiMaggio Children's Hospital/ Memorial Regional Hospital — Hollywood, Florida, United States
- Nemours Children's Specialty Care — Jacksonville, Florida, United States
- Central Florida Pulmonary Group — Orlando, Florida, United States
- Nemours Children's Hospital — Orlando, Florida, United States
- Tampa General Hospital Cardiac and Lung Transplant Clinic — Tampa, Florida, United States
- Children's Speciality Services at North Druid Hills — Atlanta, Georgia, United States
- Augusta University — Augusta, Georgia, United States
- Ann & Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Saint Francis Medical Center/ Children's Hospital of Illinois/OSF — Peoria, Illinois, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Tulane Medical Center — New Orleans, Louisiana, United States
- Maine Medical Partners — Portland, Maine, United States
- Massachusetts General Hospital Cystic Fibrosis Center — Boston, Massachusetts, United States
- Harper University Hospital — Detroit, Michigan, United States
- Banner University of Arizona Medical Center — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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