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

Use our guide to learn which trials are right for you!

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
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...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
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
?
mi
from
Akron, OH
Click here to add this to my saved trials
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....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
University of Arkansas for Medical Sciences
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...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
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
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Central Florida Pulmonary Group, PA
326 North Mills Avenue
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Children's Hospital of Philadelphia
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...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
New York Medical College
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...
?
mi
from
Valhalla, NY
Click here to add this to my saved trials
University of New Mexico Clinical and Translational Science Center
Albuquerque, New Mexico 87131
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Children's Speciality Services at North Druid Hills
Atlanta, Georgia 30324
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Augusta University
Augusta, Georgia 30912
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Austin Children's Chest Associates
Austin, Texas 78723
?
mi
from
Austin, TX
Click here to add this to my saved trials
Billings Clinic
801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
?
mi
from
Billings, MT
Click here to add this to my saved trials
Massachusetts General Hospital Cystic Fibrosis Center
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
UNC Marsico Clinical Research Center
Chapel Hill, North Carolina 27517
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Medical University of South Carolina
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...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
University of Virginia Primary Care Center
Charlottesville, Virginia 22908
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Northwestern Memorial Hospital
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois 60614
?
mi
from
Chicago, IL
Click here to add this to my saved trials
UC Health Holmes
Cincinnati, Ohio 45220
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
University Hospitals Cleveland Medical Center, Rainbow Babies & Children's Hospital
11100 Euclid Avenue
Cleveland, Ohio 44106
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Vermont Lung Center
Colchester, Vermont 05446
?
mi
from
Colchester, VT
Click here to add this to my saved trials
Dayton Children's Hospital
Dayton, Ohio 45404
?
mi
from
Dayton, OH
Click here to add this to my saved trials
National Jewish Health
1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
?
mi
from
Denver, CO
Click here to add this to my saved trials
Harper University Hospital
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
University of Florida Shands Hospital
Gainesville, Florida 32608
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Joe DiMaggio Cystic Fibrosis & Pulmonary Center/ Joe DiMaggio Children's Hospital/ Memorial Regional Hospital
3341 Johnson Street
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Nemours Children's Specialty Care
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
University of Kansas Medical Center
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...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Miller Children's Hospital / Long Beach Memorial
2801 Atlantic Avenue
Long Beach, California 90806
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Valley Children's Hospital/ Children's Hospital of Central California
Madera, California 93636
?
mi
from
Madera, CA
Click here to add this to my saved trials
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin 53792
?
mi
from
Madison, WI
Click here to add this to my saved trials
CTSI Adult Translational Research Unit/Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin 53226
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota 55404
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
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...
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
Morristown Medical Center
Morristown, New Jersey 07962
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
Tulane Medical Center
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Mount Sinai Beth Israel
New York, New York 10003
?
mi
from
New York, NY
Click here to add this to my saved trials
Women & Children's Hospital
North Adelaide,
?
mi
from
North Adelaide,
Click here to add this to my saved trials
Kaiser Permanente
Oakland, California 94612
?
mi
from
Oakland, CA
Click here to add this to my saved trials
University of Oklahoma Health Sciences Center
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...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
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...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Saint Francis Medical Center/ Children's Hospital of Illinois/OSF
Peoria, Illinois 61637
?
mi
from
Peoria, IL
Click here to add this to my saved trials
Maine Medical Partners
Portland, Maine 04102
?
mi
from
Portland, ME
Click here to add this to my saved trials
Children's Hospital of Richmond at VCU, Children's Pavilion
1000 East Broad Street
Richmond, Virginia 23298
?
mi
from
Richmond, VA
Click here to add this to my saved trials
University of California, Davis Medical Center
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
University of California at San Francisco
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
UCSF Gateway Medical Center
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
University of Washington Medical Center
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Tampa General Hospital Cardiac and Lung Transplant Clinic
1 Tampa General Circle
Tampa, Florida 33606
?
mi
from
Tampa, FL
Click here to add this to my saved trials
ProMedica Toledo Hospital/ Toledo Children's Hospital/ Pediatric Pulmonary & Cystic Fibrosis Center
Toledo, Ohio 43606
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Banner University of Arizona Medical Center
Tucson, Arizona 85724
?
mi
from
Tucson, AZ
Click here to add this to my saved trials