Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older
- Registration Number
- NCT05153317
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the long term safety, tolerability, efficacy and pharmacodynamics of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in CF participants 2 years of age and older.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 71
- Completed study drug treatment in the parent study (VX20-445-111 Part B, NCT04537793), 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 study drug intolerance in the parent study
- History of poor compliance with ELX/TEZ/IVA and/or procedures in 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 ELX/TEZ/IVA Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening. ELX/TEZ/IVA 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) From Day 1 up to Week 196
- Secondary Outcome Measures
Name Time Method Absolute Change in Sweat Chloride (SwCl) From Baseline up to Week 192 Absolute Change in Lung Clearance Index (LCI) 2.5 From Baseline up to Week 192
Trial Locations
- Locations (22)
Banner University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
Stanford University
🇺🇸Palo Alto, California, United States
Children's Hospital of Colorado
🇺🇸Aurora, Colorado, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Riley Hospital for Children at Indiana University Health
🇺🇸Indianapolis, Indiana, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
🇺🇸Minneapolis, Minnesota, United States
The Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Washington University School of Medicine / St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
NC TraCS Institute - CTRC University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Scroll for more (12 remaining)Banner University of Arizona Medical Center🇺🇸Tucson, Arizona, United States