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
We found this trial at
49
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
Click here to add this to my saved trials
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
Click here to add this to my saved trials
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
Click here to add this to my saved trials
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
Click here to add this to my saved trials
Click here to add this to my saved trials
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
Click here to add this to my saved trials
219 Bryant Street
Buffalo, New York 14222
Buffalo, New York 14222
Click here to add this to my saved trials
Click here to add this to my saved trials
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
Click here to add this to my saved trials
Click here to add this to my saved trials
100 Michigan Street Northeast
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
Click here to add this to my saved trials
1940 Alcoa Hwy
Knoxville, Tennessee 37920
Knoxville, Tennessee 37920
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
50 North Dunlap Street
Memphis, Tennessee 38103
Memphis, Tennessee 38103
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
270-05 76th Avenue
New Hyde Park, New York 11040
New Hyde Park, New York 11040
Click here to add this to my saved trials
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
Click here to add this to my saved trials
1675 West Dempster Street
Niles, Illinois 60714
Niles, Illinois 60714
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
2900 West Queen Lane
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15224
Click here to add this to my saved trials
1 Childrens Place
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Click here to add this to my saved trials
601 5th Street South
Saint Petersburg, Florida 33701
Saint Petersburg, Florida 33701
Click here to add this to my saved trials
Click here to add this to my saved trials
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
Click here to add this to my saved trials
Click here to add this to my saved trials
105 West 8th Avenue
Spokane, Washington 99204
Spokane, Washington 99204
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials