A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 3/10/2019 |
| Start Date: | March 7, 2018 |
| End Date: | February 5, 2019 |
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
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 heterozygous for
F508del and a minimal function mutation (F/MF subjects)
(TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for
F508del and a minimal function mutation (F/MF subjects)
Key Inclusion Criteria:
- Heterozygous for F508del and an MF mutation (as defined in the protocol)
- 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
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49
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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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
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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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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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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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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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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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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219 Bryant Street
Buffalo, New York 14222
Buffalo, New York 14222
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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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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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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1675 West Dempster Street
Niles, Illinois 60714
Niles, Illinois 60714
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2900 West Queen Lane
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
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Pittsburgh, Pennsylvania 15224
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1 Childrens Place
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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601 5th Street South
Saint Petersburg, Florida 33701
Saint Petersburg, Florida 33701
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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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