🏛️ Verified NIH Record • Updated 2026-08-07
Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del (NCT05331183)
A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes
🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Vertex Pharmaceuticals Incorporated
🩺 Plain-English Summary (8th-Grade Level)
This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.
Who can join: Review the eligibility criteria below.
Location: Medizinische Universität Innsbruck - Heilstättenschule Universitätsklinik — Innsbruck
Age range: 6 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (81 Sites)
Showing the first 25 of 81 sites.
- Medizinische Universität Innsbruck - Heilstättenschule Universitätsklinik — Innsbruck,
- CUB Hôpital Erasme — Brussels,
- UZ Brussel - Campus Jette — Brussels,
- Universitair Ziekenhuis Antwerpen (UZA) - Antwerp University Hospital — Edegem,
- Universitair Ziekenhuis Gent — Ghent,
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg — Leuven,
- Universite Catholique de Louvain - Pulmonology — Woluwe-Saint-Lambert,
- Stollery Children's Hospital — Edmonton,
- Le Centre de recherche du CHUM (CRCHUM) — Montreal,
- McGill University Health Centre, Glen Site, Montreal Children's Hospital — Montreal,
- Hospital for Sick Children - Pulmonology — Toronto,
- British Columbia Children's Hospital — Vancouver,
- St. Paul's Hospital - Pulmonology — Vancouver,
- Klinika Detskych Infekcnich Nemoci — Brno,
- Motol University Hospital — Prague,
- Hopital Femme Mere-Enfant — Bron,
- Centre Hospitalier Intercommunal Creteil - Pulmonology — Créteil,
- Institut Cœur Poumon, CHU de Lille — Lille,
- Hopital Nord — Marseille,
- Hopital Arnaud de Villeneuve - Service de Pneumologie et Maladies Respiratoires — Montpellier,
- Hôpital Nord Laennec — Nantes,
- CHU de Nice - Hôpital Pasteur 2 — Nice,
- Hopital Cochin - Pulmonology — Paris,
- Hopital Necker Enfants Malades - Pulmonology — Paris,
- Hopital Robert Debre - Pulmonology — Paris,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cystic Fibrosis
- Genetic Modifiers of Cystic Fibrosis (CF) Liver Disease — Chapel Hill, North Carolina
- Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age — Orange, California
- Hyperpolarized Imaging for New Treatments — Cincinnati, Ohio
- Monitoring Response to Orkambi in Cystic Fibrosis Lung Disease by Inhaled Xenon MRI — Cincinnati, Ohio
- Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older — Nedlands,
- Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis — Cincinnati, Ohio
Explore by condition: All Cystic Fibrosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.