Status:
COMPLETED
A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
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 (C...
Eligibility Criteria
Inclusion
- Key
- Subject has a confirmed diagnosis of CF and is heterozygous for F508del and either a gating or residual function mutation (F/G and F/RF genotypes)
- 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 :
August 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2020
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT04058353
Start Date
August 28 2019
End Date
June 12 2020
Last Update
July 2 2021
Active Locations (93)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Banner University of Arizona Medical Center
Tucson, Arizona, United States, 85724
3
Miller Children's Hospital / Long Beach Memorial
Long Beach, California, United States, 90806
4
Stanford University
Palo Alto, California, United States, 94304