Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
- Registration Number
- NCT06460506
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 50
- 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
Key
- History of drug intolerance in the parent study that would pose an additional risk to the participant
- Current participation in an investigational drug trial other than the parent study
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ELX/TEZ/IVA IVA Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening. ELX/TEZ/IVA ELX/TEZ/IVA Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.
- Primary Outcome Measures
Name Time Method Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 up to Week 100
- Secondary Outcome Measures
Name Time Method Absolute Change in Sweat Chloride (SwCl) From Baseline through Week 96
Trial Locations
- Locations (17)
The Kids Research Institute Australia
🇦🇺Nedlands, Australia
The Royal Children's Hospital
🇦🇺Parkville, Australia
Queensland Children's Hospital
🇦🇺South Brisbane, Australia
The Hospital for Sick Children
🇨🇦Toronto, Canada
British Columbia Children's Hospital
🇨🇦Vancouver, Canada
Juliane Marie Center, Rigshospitalet
🇩🇰Copenhagen, Denmark
Charite Paediatric Pulmonology Department
🇩🇪Berlin, Germany
Kinderklinik III, Abt. fur Pneumologie
🇩🇪Essen, Germany
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Inselspital - Universitaetsspital Bern
🇨ðŸ‡Bern, Switzerland
Kinderspital Zurich
🇨ðŸ‡Zurich, Switzerland
Children and Young Adults Research Unit
🇬🇧Cardiff, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Alder Hey Children's NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, United Kingdom
Royal Brompton Hospital
🇬🇧London, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom