A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)
Completed · Phase 3 · Has a placebo group
Conditions studied: Cystic Fibrosis
In brief
The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).
Key facts
- Study ID
- NCT05033080
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 435
- Starts
- 2021-09-14
- Expected to finish
- 2023-11-21
- Last updated by the study team
- 2024-10-03
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
- Arkansas Children's Hospital — 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
- Kaiser Permanente — Oakland, 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
- Children's Hospital of Colorado — Aurora, Colorado, United States
- National Jewish Health — Denver, Colorado, United States
- University of Florida, Shands Hospital — Gainesville, Florida, United States
- Joe DiMaggio Cystic Fibrosis & Pulmonary Center — Hollywood, Florida, United States
- Central Florida Pulmonary Group, PA — Orlando, Florida, United States
- Nemours Children's Hospital — Orlando, Florida, United States
- Johns Hopkins All Children's Hospital Outpatient Care Center — St. Petersburg, Florida, United States
- The Emory Clinic at Chantilly — Atlanta, Georgia, United States
- Augusta University — Augusta, Georgia, United States
- St. Luke's Cystic Fibrosis Center of Idaho — Boise, Idaho, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Indiana University — Indianapolis, Indiana, United States
- Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- University of Kentucky — Lexington, Kentucky, United States
- Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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