A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy



Status:Enrolling by invitation
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:4/3/2019
Start Date:October 9, 2018
End Date:June 2021

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A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation

This study will evaluate the long-term safety and tolerability of VX-445 in triple
combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis
(CF) who are homozygous or heterozygous for the F508del mutation


Inclusion Criteria:

- Completed study drug treatment in a parent study; or had study drug interruption(s) in
a parent study but completed study visits up to the last scheduled visit of the
Treatment Period in the parent study.

Exclusion Criteria:

- History of drug intolerance in a parent study that would pose an additional risk to
the subject in the opinion of the investigator.

- Current participation in an investigational drug trial (other than a parent study)

Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
49
sites
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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4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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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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529 West Markham Street
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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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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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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326 North Mills Avenue
Orlando, Florida 32803
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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Albuquerque, New Mexico 87131
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Atlanta, GA
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Augusta, Georgia 30912
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2800 10th Avenue North
Billings, Montana 59101
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Chapel Hill, North Carolina 27517
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171 Ashley Avenue
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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Charlottesville, Virginia 22908
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Cincinnati, Ohio 45220
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Colchester, Vermont 05446
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dayton, Ohio 45404
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Detroit, Michigan 48201
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Hollywood, FL
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Jacksonville, Florida 32207
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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2801 Atlantic Avenue
Long Beach, California 90806
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Madera, California 93638
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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, New Jersey 07962
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New Orleans, Louisiana 70112
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North Adelaide,
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Oakland, California 94612
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940 NE 13th St
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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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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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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Peoria, IL
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Portland, Maine 04102
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1000 East Broad Street
Richmond, Virginia 23298
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San Francisco, California 94143
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1 Tampa General Circle
Tampa, Florida 33606
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Toledo, OH
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