A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | August 8, 2017 |
| End Date: | February 28, 2018 |
A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis
This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor
(TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the
safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with
cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane
conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del
mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or
TEZ/IVA (F/MF genotypes).
(TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the
safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with
cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane
conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del
mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or
TEZ/IVA (F/MF genotypes).
Key Inclusion Criteria:
- Body weight ≥35 kg.
- Subjects must have an eligibleCFTR genotype.
- Part 1 and Part 3: Heterozygous for F508del and an MF mutation (F/MF)
- Part 2: Homozygous for F508del (F/F)
- FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height
Key Exclusion Criteria:
- History of clinically significant cirrhosis with or without portal hypertension.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Lung infection with organisms associated with a more rapid decline in pulmonary
status.
- History of solid organ or hematological transplantation.
Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
26
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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1601 Northwest 12th Avenue
Miami, Florida 33136
Miami, Florida 33136
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University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Baltimore, Maryland 21287
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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1940 Alcoa Hwy
Knoxville, Tennessee 37920
Knoxville, Tennessee 37920
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50 North Dunlap Street
Memphis, Tennessee 38103
Memphis, Tennessee 38103
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1675 Dempster Street
Morton Grove, Illinois 60053
Morton Grove, Illinois 60053
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675 Hoes Lane West
New Brunswick, New Jersey 08902
New Brunswick, New Jersey 08902
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Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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270-05 76th Avenue
New Hyde Park, New York 11040
New Hyde Park, New York 11040
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Pittsburgh, Pennsylvania 15224
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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105 West 8th Avenue
Spokane, Washington 99204
Spokane, Washington 99204
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