Status:
COMPLETED
Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
This study evaluated the efficacy, pharmacodynamics (PD) and safety of ELX/TEZ/IVA in participants 6 years of age and older with a non-F508del ELX/TEZ/IVA-responsive cystic fibrosis transmembrane cond...
Eligibility Criteria
Inclusion
- Key
- Participant has a qualifying ELX/TEZ/IVA-responsive CFTR mutation and does not have an exclusionary CFTR mutation
- Forced expiratory volume in 1 second (FEV1) value \>=40% and \<=100% of predicted mean for age, sex, and height
- Key
Exclusion
- History of solid organ or hematological transplantation
- Clinically significant cirrhosis with or without portal hypertension
- Lung infection with organisms associated with a more rapid decline in pulmonary status
- Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2023
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT05274269
Start Date
May 9 2022
End Date
July 5 2023
Last Update
August 1 2024
Active Locations (90)
Enter a location and click search to find clinical trials sorted by distance.
1
Medizinische Universität Innsbruck
Innsbruck, Austria
2
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, Belgium
3
Universitair Ziekenhuis Brussel - Campus Jette
Brussels, Belgium
4
Universitair Ziekenhuis Antwerpen (UZA) - Antwerp University Hospital
Edegem, Belgium