A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis
Completed · Phase 2 · Has a placebo group
Conditions studied: Cystic Fibrosis
In brief
This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).
Key facts
- Study ID
- NCT03224351
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 124
- Starts
- 2017-08-08
- Expected to finish
- 2018-02-28
- Last updated by the study team
- 2021-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States
- University of Miami/Miller School of Medicine — Miami, Florida, United States
- Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants — Morton Grove, Illinois, United States
- Indiana University Health — Indianapolis, Indiana, United States
- The University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- The Johns Hopkins Hospital/ Johns Hopkins Hospital, David Rubenstein Child Health Building — 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
- Children's Mercy Hospital — Kansas City, Missouri, United States
- Rutgers-Robert Wood Johnson Medical School/ Rutgers-Robert Wood Johnson Medical School, Clinical Research Center — New Brunswick, New Jersey, United States
- Albany Medical College — Albany, New York, United States
- Northwell Health, Long Island Jewish Medical Center — New Hyde Park, New York, United States
- Columbia University Medical Center — New York, New York, United States
- SUNY Upstate Medical University — Syracuse, New York, United States
- Respiratory Diseases of Children & Adolescents — Oklahoma City, Oklahoma, United States
- Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Sanford Research / USD — Sioux Falls, South Dakota, United States
- University of Tennessee Medical Center-Adult Cystic Fibrosis Clinic — Knoxville, Tennessee, United States
- Children's Foundation Research Center / Le Bonheur Children's Hospital — Memphis, Tennessee, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- University of Utah / Primary Children's Medical Center — Salt Lake City, Utah, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- Providence Pediatric Pulmonary & Allergy/Immunology Clinic — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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