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

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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-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)


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
Helen DeVos Children's Hospital CF Center
100 Michigan Street Northeast
Grand Rapids, Michigan 49503
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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Cincinnati Children's Hospital Medical Center
3333 Burnet Avenue # Mlc3008
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
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Mississippi Medical Center
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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Children's Mercy Hospital
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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University of Miami Miller School of Medicine
1601 Northwest 12th Avenue
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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Miami, FL
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Univ of Minnesota
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Vanderbilt University Medical Center
1211 Medical Center Dr
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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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
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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Portland, OR
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Albany Medical College
47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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University of Michigan Health System
1500 E Medical Center Dr
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
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Johns Hopkins Hospital
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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St. Luke's CF Center of Idaho
Boise, Idaho 83712
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Boise, ID
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Boston Children's Hospital
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Lung and Cystic Fibrosis Center at Women and Children's Hospital of Buffalo
219 Bryant Street
Buffalo, New York 14222
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Buffalo, NY
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Clinical Research of Charlotte
Charlotte, North Carolina 28277
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Charlotte, NC
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Duke Univ Med Ctr
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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
801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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The Cystic Fibrosis Center of Chicago
Glenview, Illinois 60025
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Glenview, IL
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Hartford Health
Hartford, Connecticut 06106
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Indiana Clinical Research Center, IU Health University Hospital
Indianapolis, Indiana 46202
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Indianapolis, IN
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University of Iowa Hospitals and Clinics
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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University of Tennessee Medical Center-Adult Cystic Fibrosis Clinic
1940 Alcoa Hwy
Knoxville, Tennessee 37920
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Knoxville, TN
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Dartmouth-Hitchcock Medical Center - Lebanon
Lebanon, New Hampshire 03756
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Lebanon, NH
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Kentucky Clinic
740 South Limestone
Lexington, Kentucky 40536
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Lexington, KY
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Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky 40202
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Louisville, KY
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Alfred Hospital
Melbourne, Victoria 3004
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Melbourne,
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Children's Foundation Research Center / Le Bonheur Children's Hospital
50 North Dunlap Street
Memphis, Tennessee 38103
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Memphis, TN
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Nicklaus Children's Hospital
Miami, Florida 33155
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Miami, FL
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Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey 08903
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New Brunswick, NJ
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Yale New-Haven Medical Center
New Haven, Connecticut 06504
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New Haven, CT
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Northwell Health, Long Island Jewish Medical Center
270-05 76th Avenue
New Hyde Park, New York 11040
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New Hyde Park, NY
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Columbia University Medical Center
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants
1675 West Dempster Street
Niles, Illinois 60714
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Niles, IL
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Respiratory Diseases of Children and Adolescents
Oklahoma City, Oklahoma
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Oklahoma City, OK
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Arnold Palmer Hospital
Orlando, Florida 32806
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Orlando, FL
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Stanford University
Palo Alto, California 94304
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Palo Alto, CA
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Drexel University College of Medicine/ Drexel Adult Cystic Fibrosis Center
2900 West Queen Lane
Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15224
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Washington University School of Medicine and St. Louis Children's Hospital
1 Childrens Place
Saint Louis, Missouri 63110
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Saint Louis, MO
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Johns Hopkins All Children's Hospital Outpatient Care Center
601 5th Street South
Saint Petersburg, Florida 33701
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Saint Petersburg, FL
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University of Utah / Primary Childrens Medical Center
Salt Lake City, Utah 84132
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Salt Lake City, UT
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Seattle Children's Hospital
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Sanford Research/USD
Sioux Falls, South Dakota 57104
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Sioux Falls, SD
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Providence Pediatric Pulmonary & Allergy/Immunology Clinic
105 West 8th Avenue
Spokane, Washington 99204
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Spokane, WA
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SUNY Upstate Medical University
750 East Adams Street
Syracuse, New York 13210
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Syracuse, NY
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University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
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Worcester, MA
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