Status:
ACTIVE_NOT_RECRUITING
Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
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 transmembran...
Eligibility Criteria
Inclusion
- Key
- Part A: Completed study drug treatment in parent study or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study
- Part B: Completed study drug treatment in Part A or had study drug interruption(s) in Part A but completed study visits up to the last scheduled visit of the treatment period of Part A
- Key
Exclusion
- History of study drug intolerance in the parent study
- Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
November 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2027
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT05331183
Start Date
November 23 2022
End Date
April 6 2027
Last Update
December 3 2025
Active Locations (81)
Enter a location and click search to find clinical trials sorted by distance.
1
Medizinische Universität Innsbruck - Heilstättenschule Universitätsklinik
Innsbruck, Austria
2
CUB Hôpital Erasme
Brussels, Belgium
3
UZ Brussel - Campus Jette
Brussels, Belgium
4
Universitair Ziekenhuis Antwerpen (UZA) - Antwerp University Hospital
Edegem, Belgium