A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 3/8/2019 |
| Start Date: | August 3, 2018 |
| End Date: | December 28, 2018 |
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor
(TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the
F508del mutation (F/F)
(TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the
F508del mutation (F/F)
Key Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
29
sites
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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New York Medical College The College was founded in 1860 by a group of New...
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Boston, Massachusetts 02114
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Cleveland, Ohio 44106
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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3341 Johnson Street
Hollywood, Florida 33021
Hollywood, Florida 33021
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West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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1 Tampa General Circle
Tampa, Florida 33606
Tampa, Florida 33606
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Toledo, Ohio 43606
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