Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/6/2019 |
| Start Date: | August 23, 2018 |
| End Date: | September 2020 |
| Contact: | Medical Information |
| Email: | medicalinfo@vrtx.com |
| Phone: | 617-341-6777 |
A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and
ivacaftor (IVA) in subjects 1 to less than 2 years of age with cystic fibrosis (CF),
homozygous for F508del (F/F).
ivacaftor (IVA) in subjects 1 to less than 2 years of age with cystic fibrosis (CF),
homozygous for F508del (F/F).
Key Inclusion Criteria:
- Subjects will be 1 to less than 2 years of age on Day 1 of the relevant part of the
study.
- Homozygous for F508del (F/F).
Key Exclusion Criteria:
- Any clinically significant laboratory abnormalities at the Screening Visit that would
interfere with the study assessments or pose an undue risk for the subject.
- Solid organ or hematological transplantation.
Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
15
sites
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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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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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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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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Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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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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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Minneapolis, Minnesota 55404
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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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