A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)



Status:Active, not recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:12/6/2018
Start Date:June 15, 2018
End Date:August 2019

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Trial Summary
Trial Overview
Inclusion Criteria

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 Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

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 heterozygous for
F508del and a minimal function mutation (F/MF subjects).


Key Inclusion Criteria:

- Heterozygous for the F508del mutation (F/MF)

- 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
53
sites
University of Washington Medical Center
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
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Akron Children's Hospital
1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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Nationwide Children's Hospital
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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University of Arkansas for Medical Sciences
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
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Childrens Hospital Los Angeles
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
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 The King's Daughters
601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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Central Florida Pulmonary Group, PA
326 North Mills Avenue
Orlando, Florida 32803
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Orlando, FL
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Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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New York Medical College
40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
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University of New Mexico Clinical and Translational Science Center
Albuquerque, New Mexico 87131
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Albuquerque, NM
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Children's Speciality Services at North Druid Hills
Atlanta, Georgia 30324
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Atlanta, GA
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Augusta University
Augusta, Georgia 30912
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Augusta, GA
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Austin Children's Chest Associates
Austin, Texas 78723
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Austin, TX
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Billings Clinic
801 North 29th Street
Billings, Montana 59107
406-238-2500
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Massachusetts General Hospital Cystic Fibrosis Center
Boston, Massachusetts 02114
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Boston, MA
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UNC Marsico Clinical Research Center
Chapel Hill, North Carolina 27517
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Chapel Hill, NC
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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University of Virginia Primary Care Center
Charlottesville, Virginia 22908
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Northwestern Memorial Hospital
251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
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Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois 60614
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Chicago, IL
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UC Health Holmes
Cincinnati, Ohio 45220
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Cincinnati, OH
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University Hospitals Cleveland Medical Center, Rainbow Babies & Children's Hospital
11100 Euclid Avenue
Cleveland, Ohio 44106
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Cleveland, OH
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Vermont Lung Center
Colchester, Vermont 05446
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Colchester, VT
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Dayton Children's Hospital
Dayton, Ohio 45404
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National Jewish Health
1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
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Harper University Hospital
Detroit, Michigan 48201
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University of Florida Shands Hospital
Gainesville, Florida 32608
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Joe DiMaggio Cystic Fibrosis & Pulmonary Center/ Joe DiMaggio Children's Hospital/ Memorial Regional Hospital
3341 Johnson Street
Hollywood, Florida 33021
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Hollywood, FL
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Nemours Children's Specialty Care
Jacksonville, Florida 32207
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Jacksonville, FL
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University of Kansas Medical Center
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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Miller Children's Hospital / Long Beach Memorial
2801 Atlantic Avenue
Long Beach, California 90806
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Long Beach, CA
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Valley Children's Hospital/ Children's Hospital of Central California
Madera, California 93636
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Madera, CA
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University of Wisconsin Hospitals and Clinics
Madison, Wisconsin 53792
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Madison, WI
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CTSI Adult Translational Research Unit/Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota 55404
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West Virginia University
Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Morristown Medical Center
Morristown, New Jersey 07962
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Tulane Medical Center
New Orleans, Louisiana 70112
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Mount Sinai Beth Israel
New York, New York 10003
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Women & Children's Hospital
North Adelaide,
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Kaiser Permanente
Oakland, California 94612
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University of Oklahoma Health Sciences Center
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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Nebraska Medical Center
4242 Dewey Ave
Omaha, Nebraska 68105
(800) 922-0000
Nebraska Medical Center Formed in 1997 by combining the operations of University Hospital, Bishop Clarkson...
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Nemours Children's Hospital
13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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Saint Francis Medical Center/ Children's Hospital of Illinois/OSF
Peoria, Illinois 61637
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Peoria, IL
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Maine Medical Partners
Portland, Maine 04102
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Children's Hospital of Richmond at VCU, Children's Pavilion
1000 East Broad Street
Richmond, Virginia 23298
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University of California, Davis Medical Center
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
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University of California at San Francisco
San Francisco, California 94143
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UCSF Gateway Medical Center
San Francisco, California 94143
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Tampa General Hospital Cardiac and Lung Transplant Clinic
1 Tampa General Circle
Tampa, Florida 33606
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Tampa, FL
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ProMedica Toledo Hospital/ Toledo Children's Hospital/ Pediatric Pulmonary & Cystic Fibrosis Center
Toledo, Ohio 43606
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Banner University of Arizona Medical Center
Tucson, Arizona 85724
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