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

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

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
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...
?
mi
from
Albany, NY
Click here to add this to my saved trials
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...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
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...
?
mi
from
Miami, FL
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
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...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
The Johns Hopkins Hospital/ Johns Hopkins Hospital, David Rubenstein Child Health Building
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
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....
?
mi
from
Boston, MA
Click here to add this to my saved trials
Cork University Hospital
Cork,
?
mi
from
Cork,
Click here to add this to my saved trials
Helen DeVos Children's Hospital CF Center
100 Michigan Street Northeast
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Indiana University Health
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
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...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
University of Tennessee Medical Center-Adult Cystic Fibrosis Clinic
1940 Alcoa Hwy
Knoxville, Tennessee 37920
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Children's Foundation Research Center / Le Bonheur Children's Hospital
50 North Dunlap Street
Memphis, Tennessee 38103
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants
1675 Dempster Street
Morton Grove, Illinois 60053
?
mi
from
Morton Grove, IL
Click here to add this to my saved trials
Rutgers-Robert Wood Johnson Medical School/ Rutgers-Robert Wood Johnson Medical School, Clinical Research Center
675 Hoes Lane West
New Brunswick, New Jersey 08902
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
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...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Northwell Health, Long Island Jewish Medical Center
270-05 76th Avenue
New Hyde Park, New York 11040
?
mi
from
New Hyde Park, NY
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
Respiratory Diseases of Children and Adolescents
Oklahoma City, Oklahoma
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15224
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
University of Utah / Primary Childrens Medical Center
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
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...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sanford Research/USD
Sioux Falls, South Dakota 57104
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Providence Pediatric Pulmonary & Allergy/Immunology Clinic
105 West 8th Avenue
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
SUNY Upstate Medical University
750 East Adams Street
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
?
mi
from
Worcester, MA
Click here to add this to my saved trials