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
- Diseases
- Cystic fibrosis
- 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
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queensland Children's Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| British Columbia's Children's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Birmingham Children's Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Children's Health Ireland at Temple Street Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Children's Health Ireland at Crumlin Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Clinical Research of Charlotte Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Ann & Robert Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| The Children's Mercy Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Northwell Health/Long Island Jewish Medical Center Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Children's Hospital of Orange County Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.