Status:
COMPLETED
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy, safety, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (...
Eligibility Criteria
Inclusion
- Key
- Homozygous for the F508del mutation (F/F)
- Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height
- 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 :
October 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2020
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04105972
Start Date
October 3 2019
End Date
July 24 2020
Last Update
August 18 2021
Active Locations (35)
Enter a location and click search to find clinical trials sorted by distance.
1
The Prince Charles Hospital
Chermside, Australia
2
Institute for Respiratory Health
Nedlands, Australia
3
Perth Children's Hospital
Nedlands, Australia
4
John Hunter Hospital & Hunter Medical Research Institute and John Hunter Children's Hospital
New Lambton, Australia