A Study Evaluating the Long-term Safety of VX-445 Combination Therapy

Completed · Phase 3

Conditions studied: Cystic Fibrosis

In brief

This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).

Key facts

Study ID

NCT04043806

Run by

Vertex Pharmaceuticals Incorporated

People needed

458

Starts

2019-08-09

Expected to finish

2022-12-14

Last updated by the study team

2023-07-06

Who can join

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

You may qualify if…

• Currently participating in study VX17-659-105 (NCT03447262)

You may not qualify if…

• History of drug intolerance in study VX17-659-105 that would pose an additional risk to the participant in the opinion of the investigator
• Current participation in an investigational drug trial (other than study VX17-659-105)
• 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 Hospital — New Haven, Connecticut, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Arnold Palmer Hospital Pulmonary and Sleep Medicine — 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 Institute — Glenview, Illinois, United States
• Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants — Niles, Illinois, United States
• Indiana University — 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
• 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
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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