A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

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 homozygous for the F508del mutation (F/F).

Key facts

Study ID

NCT03460990

Run by

Vertex Pharmaceuticals Incorporated

People needed

116

Starts

2018-05-01

Expected to finish

2018-10-08

Last updated by the study team

2019-10-17

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Yale New Haven Medical Center — New Haven, Connecticut, United States
• University of Miami/Miller School of Medicine — Miami, Florida, United States
• St. Luke's CF Center of Idaho — Boise, Idaho, 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
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Helen DeVos Children's Hospital CF Center — Grand Rapids, Michigan, 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
• Rutgers-Robert Wood Johnson Medical School — 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
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Respiratory Diseases of Children and Adolescents — Oklahoma City, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, 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

Full record on ClinicalTrials.gov

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