Status:
COMPLETED
Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This study evaluated the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibr...
Eligibility Criteria
Inclusion
- Key
- Completed study drug treatment in parent study (VX18-445-104); 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
- Key
Exclusion
- History of study drug intolerance in parent study
- Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
December 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT04058366
Start Date
December 5 2019
End Date
December 16 2022
Last Update
January 16 2024
Active Locations (84)
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1
Banner University of Arizona Medical Center
Tucson, Arizona, United States, 85724
2
Miller Children's Hospital / Long Beach Memorial
Long Beach, California, United States, 90806
3
Stanford University
Palo Alto, California, United States, 94304
4
University of California Davis Medical Center
Sacramento, California, United States, 95817