A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR Mutation



Status:Active, not recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:6 - Any
Updated:3/3/2019
Start Date:April 25, 2018
End Date:December 2020

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation

This study will evaluate the long-term safety and tolerability of tezacaftor in combination
with ivacaftor (TEZ/IVA) in subjects with cystic fibrosis (CF) aged 6 years and older,
homozygous or heterozygous for the F508del mutation.


Inclusion Criteria:

- Completed the Week 24 Visit in Study 113 Part B or the Week 8 Visit in Study 115.

- Eligible CFTR Mutation.

Exclusion Criteria:

- Pregnant and nursing females.

- History of poor compliance with study drug and/or procedures in a previous study as
deemed by the investigator.

- Ongoing participation in another study with investigational drug.

Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
29
sites
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 Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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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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Houston, TX
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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...
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Los Angeles, CA
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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
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Norfolk, VA
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Children's Hospital of Pittsburgh of UPMC
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Pittsburgh, PA
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Providence Alaska Medical Center
Anchorage, Alaska 99508
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Anchorage, AK
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Children's Speciality Services at North Druid Hills
Atlanta, Georgia 30324
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Atlanta, GA
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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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Aurora, CO
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Austin Children's Chest Associates
Austin, Texas 78723
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Austin, TX
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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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Boston, MA
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UBMD Pediatrics/ CF Center of Western New York
Buffalo, New York 14203
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Buffalo, NY
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Medical University of South Carolina
Charleston, South Carolina 29425
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Charleston, SC
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Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
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Cleveland, OH
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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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Fort Worth, TX
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Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana 46202
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Indianapolis, IN
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Arkansas Children's Hospital
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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Dartmouth-Hitchcock Medical Center
Manchester, New Hampshire 03104
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Manchester, NH
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Children's Hospital of Wisconsin
9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Milwaukee, WI
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Childrens Hospital & Clinics of Minnesota
Minneapolis, Minnesota 55404
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Minneapolis, MN
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Perth Children's Hospital
Nedlands,
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Nedlands,
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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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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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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 Children's Speciality Clinic
Sioux Falls, South Dakota 57105
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Sioux Falls, SD
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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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Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware 19803
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Wilmington, DE
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Wake Forest Baptist Health
Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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