A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation

Completed · Phase 3

Conditions studied: Cystic Fibrosis

In brief

This study evaluates the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.

Key facts

Study ID

NCT03537651

Run by

Vertex Pharmaceuticals Incorporated

People needed

130

Starts

2018-04-25

Expected to finish

2023-09-29

Last updated by the study team

2024-04-19

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed the Week 24 Visit in Study 113 Part B or the Week 8 Visit in Study 115
• Eligible CFTR Mutation

You may not qualify if…

• Pregnant and nursing females
• History of poor compliance with study drug and/or procedures in a previous study as deemed by the investigator
• Ongoing participation in another study with investigational drug
• Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Nemours/ Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Johns Hopkins All Children's Hospital Outpatient Care Center — St. Petersburg, Florida, United States
• Center for Advanced Pediatrics — Atlanta, Georgia, United States
• St. Luke's CF Center of Idaho — Boise, Idaho, United States
• Riley Hospital for Children Indiana University Health — Indianapolis, Indiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Hospital & Clinics of Minnesota — Minneapolis, Minnesota, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• Dartmouth Hitchcock Medical Center — Manchester, New Hampshire, United States
• UBMD Pediatrics/ CF Center of Western New York — Buffalo, New York, United States
• Columbia University Medical Center — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
• Sanford Children's Speciality Clinic — Sioux Falls, South Dakota, United States
• Austin Children's Chest Associates — Austin, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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