NCT06460506Active, not recruitingPhase 3
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 Months of Age and Older
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 10 Jun 2024
- Start date
- 21 Nov 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Diseases
- Cystic fibrosis
- NCT number
- NCT06460506
- EU CT number
- 2023-509563-24-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 50
- From 21 Nov 2024 to the primary completion date, 30 Sept 2027
- 18 sites in 7 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.
Prior treatment
- Current participation in an investigational drug trial other than the parent study
- Other protocol defined Inclusion/Exclusion criteria may apply.
Other illness
- History of drug intolerance in the parent study that would pose an additional risk to the participant
Who the study is looking for
- Completed study drug treatment in the parent study VX22-445-122 Part B (NCT05882357) OR had study drug interruption(s) in the parent study but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the Treatment Period of the parent study
Age in the registry: 12 months to 17 years · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Kids Research Institute Australia Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| The Royal Children's Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Queensland Children's Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| British Columbia Children's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Inselspital - Universitaetsspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Kinderspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| Children and Young Adults Research Unit Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Leeds General Infirmary Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Alder Hey Children's NHS Foundation Trust Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Great Ormond Street Hospital for Children Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Brompton Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.