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 |
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.
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
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
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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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Cleveland, Ohio 44106
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
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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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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601 5th Street South
Saint Petersburg, Florida 33701
Saint Petersburg, Florida 33701
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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