A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:August 8, 2017
End Date:February 28, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis

This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor
(TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the
safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with
cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane
conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del
mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or
TEZ/IVA (F/MF genotypes).


Key Inclusion Criteria:

- Body weight ≥35 kg.

- Subjects must have an eligibleCFTR genotype.

- Part 1 and Part 3: Heterozygous for F508del and an MF mutation (F/MF)

- Part 2: Homozygous for F508del (F/F)

- FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height

Key Exclusion Criteria:

- History of clinically significant cirrhosis with or without portal hypertension.

- Glucose-6-phosphate dehydrogenase (G6PD) deficiency

- Lung infection with organisms associated with a more rapid decline in pulmonary
status.

- History of solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
26
sites
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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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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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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Nashville, TN
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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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Albany, NY
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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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Ann Arbor, MI
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The Johns Hopkins Hospital/ Johns Hopkins Hospital, David Rubenstein Child Health Building
Baltimore, Maryland 21287
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Baltimore, MD
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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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Boston, MA
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Cork University Hospital
Cork,
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Cork,
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Helen DeVos Children's Hospital CF Center
100 Michigan Street Northeast
Grand Rapids, Michigan 49503
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Grand Rapids, MI
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Indiana University Health
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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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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Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants
1675 Dempster Street
Morton Grove, Illinois 60053
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Morton Grove, IL
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Rutgers-Robert Wood Johnson Medical School/ Rutgers-Robert Wood Johnson Medical School, Clinical Research Center
675 Hoes Lane West
New Brunswick, New Jersey 08902
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New Brunswick, NJ
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Yale-New Haven Hospital
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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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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New York, NY
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Respiratory Diseases of Children and Adolescents
Oklahoma City, Oklahoma
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Oklahoma City, OK
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Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15224
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Pittsburgh, PA
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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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Seattle, WA
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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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