Status:
COMPLETED
A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (...
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 :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2018
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03460990
Start Date
May 1 2018
End Date
October 8 2018
Last Update
October 17 2019
Active Locations (46)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Yale New Haven Medical Center
New Haven, Connecticut, United States, 06511
3
University of Miami/Miller School of Medicine
Miami, Florida, United States, 33136
4
St. Luke's CF Center of Idaho
Boise, Idaho, United States, 83712