A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy

Stopped early · Phase 3

Conditions studied: Cystic Fibrosis

In brief

This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation.

Key facts

Study ID

NCT03447262

Run by

Vertex Pharmaceuticals Incorporated

People needed

484

Starts

2018-07-13

Expected to finish

2020-09-09

Last updated by the study team

2022-01-25

Who can join

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

You may qualify if…

• Completed study drug treatment in a parent study; or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study.

You may not qualify if…

• History of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator.
• Current participation in an investigational drug trial (other than a parent study)
• Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Stanford University — Palo Alto, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Yale New Haven Medical Center — New Haven, Connecticut, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Orlando Health, Inc.- Arnold Palmer Hospital for Children (APH) — Orlando, Florida, United States
• Johns Hopkins All Children's Hospital Outpatient Care Center — St. Petersburg, Florida, United States
• St. Luke's CF Center of Idaho — Boise, Idaho, United States
• Cystic Fibrosis Center of Chicago — Glenview, Illinois, 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
• University of Kentucky — Lexington, Kentucky, United States
• Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Michigan Medicine — Ann Arbor, Michigan, United States
• Spectrum Health Medical Group Adult Cystic Fibrosis Care Center — Grand Rapids, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine/ St. Louis Children's Hospital — St Louis, Missouri, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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