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NCT04183790CompletedPhase 3

Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA TC Combination Therapy in Participants With Cystic Fibrosis Who Are 6 Years of Age and Older

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of ELX/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older

Source: ClinicalTrials.gov · Last updated 18 May 2025

Brief summary (registry, in English)

The study evaluates the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in participants with cystic fibrosis (CF).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
64 (actual)
First submitted
28 Nov 2019
Start date
17 Feb 2020
Primary completion date
24 Feb 2024
Lead sponsor
Vertex Pharmaceuticals Incorporated
NCT number
NCT04183790
EudraCT number
2019-001827-11

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 64
  • From 17 Feb 2020 to the primary completion date, 24 Feb 2024
  • 21 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of study drug intolerance in parent study
    • Other protocol defined Inclusion/Exclusion criteria may apply.

Who the study is looking for

  • Completed study drug treatment in parent study (VX18-445-106 Part B, NCT03691779), or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study

Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Queensland Children's Hospital
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South BrisbaneAustraliaUnknown status
The Children's Hospital at Westmead
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WestmeadAustraliaUnknown status
The Hospital for Sick Children
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TorontoCanadaUnknown status
British Columbia's Children's Hospital
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VancouverCanadaUnknown status
Birmingham Children's Hospital NHS Foundation Trust
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BirminghamUnited KingdomUnknown status
Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital
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LondonUnited KingdomUnknown status
Children's Health Ireland at Temple Street
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DublinIrelandUnknown status
Children's Health Ireland at Crumlin
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DublinIrelandUnknown status
Children's Hospital Colorado
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AuroraUnited StatesUnknown status
Boston Children's Hospital
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BostonUnited StatesUnknown status
Clinical Research of Charlotte
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CharlotteUnited StatesUnknown status
Ann & Robert Lurie Children's Hospital of Chicago
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ChicagoUnited StatesUnknown status
Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center
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ClevelandUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
Texas Children's Hospital
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HoustonUnited StatesUnknown status
The Children's Mercy Hospital
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Kansas CityUnited StatesUnknown status
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
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MinneapolisUnited StatesUnknown status
Northwell Health/Long Island Jewish Medical Center
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New Hyde ParkUnited StatesUnknown status
Children's Hospital of Orange County
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OrangeUnited StatesUnknown status
Oregon Health Science University
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PortlandUnited StatesUnknown status
Seattle Children's Hospital
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SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.