Status:
COMPLETED
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous fo...
Eligibility Criteria
Inclusion
- Key
- Completed study drug treatment in parent study (VX18-445-109); 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 :
May 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2022
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT04362761
Start Date
May 4 2020
End Date
December 21 2022
Last Update
July 28 2023
Active Locations (29)
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1
The Prince Charles Hospital
Chermside, Australia
2
Institute for Respiratory Health
Nedlands, Australia
3
Telethon Kids Institute, Perth Children's Hospital
Nedlands, Australia
4
The Royal Children's Hospital
Parkville, VIC, Australia