A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation
Completed · Phase 3 · Has a placebo group
Conditions studied: Cystic Fibrosis
In brief
The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation.
Key facts
- Study ID
- NCT05076149
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 597
- Starts
- 2021-10-27
- Expected to finish
- 2023-11-30
- Last updated by the study team
- 2024-06-13
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
- Cook Children's Health Care System — Fort Worth, Texas, United States
- Royal Manchester Children's Hospital — Manchester, United Kingdom
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Children's Hospital of Orange County — Orange, California, United States
- University of California Davis Medical Center — Sacramento, California, United States
- Children's Hospital of Colorado — Aurora, Colorado, United States
- National Jewish Health — Denver, Colorado, United States
- Yale New Haven Hospital — New Haven, Connecticut, United States
- Nemours Children's Specialty Care — Jacksonville, Florida, United States
- University of Miami Miller School of Medicine — Miami, Florida, United States
- Central Florida Pulmonary Group, PA — Orlando, Florida, United States
- Nemours Children's Specialty Care, Pensacola — Pensacola, 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
- 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 Kentucky — Lexington, Kentucky, United States
- Tulane Medical Center — New Orleans, Louisiana, United States
- Maine Medical Partners — Portland, Maine, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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