Status:
COMPLETED
A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-11 years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who a...
Eligibility Criteria
Inclusion
- Key
- Heterozygous for the F508del mutation (F/MF)
- Forced expiratory volume in 1 second (FEV1) value greater than equal to(≥) 70%
- Key
Exclusion
- Clinically significant cirrhosis with or without portal hypertension
- Lung infection with organisms associated with a more rapid decline in pulmonary status
- Solid organ or hematological transplantation
- Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
June 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2021
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT04353817
Start Date
June 19 2020
End Date
May 17 2021
Last Update
July 26 2022
Active Locations (34)
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1
Telethon Kids Institute
Nedlands, Australia
2
Queensland Children's Hospital
South Brisbane, Australia
3
The Children's Hospital at Westmead
Westmead, Australia
4
McGill University Health Centre, Glen Site, Montreal Children's Hospital
Montreal, Canada