🏛️ Verified NIH Record • Updated 2026-06-03
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older (NCT06460506)
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
🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Vertex Pharmaceuticals Incorporated
🩺 Plain-English Summary (8th-Grade Level)
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
Who can join: Review the eligibility criteria below.
Location: The Kids Research Institute Australia — Nedlands
Age range: 12 Months
🧪 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 (18 Sites)
- The Kids Research Institute Australia — Nedlands,
- The Royal Children's Hospital — Parkville,
- Queensland Children's Hospital — South Brisbane,
- The Hospital for Sick Children — Toronto,
- British Columbia Children's Hospital — Vancouver,
- Juliane Marie Center, Rigshospitalet — Copenhagen,
- Charité Universitätsmedizin BerlinX — Berlin,
- Kinderklinik III, Abt. fur Pneumologie — Essen,
- Medizinische Hochschule Hannover — Hanover,
- Erasmus Medical Center — Rotterdam,
- Inselspital - Universitaetsspital Bern — Bern,
- Kinderspital Zurich — Zurich,
- Children and Young Adults Research Unit — Cardiff,
- Leeds General Infirmary — Leeds,
- Alder Hey Children's NHS Foundation Trust — Liverpool,
- Great Ormond Street Hospital for Children — London,
- Royal Brompton Hospital — London,
- Southampton General Hospital — Southampton,
💰 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
- 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.