Vertex Lumacaftor (VX-809) and Ivacaftor in Children with CF aged 6 to 11 years and have two copies of the delF508 CFTR mutation
Number of Participants Being Recruited:
Single / Multi-Center:
STUDY BACKGROUND INFORMATION:
This is a phase 1, open- label trial to look at the pharmacokinetics and safety of lumacaftor (VX-809) in combination with ivacaftor in children aged 6 to 11 years who have two copies of the F508del-CFTR mutation.
6 Years - 11 Years
P. aeruginosa status:
B. cepacia status:
Other Primary Eligibility Requirements:
Potential participants must be homozygous for the F508del CFTR mutation.
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
University of Alabama at Birmingham (Adult), Birmingham, AL, 35294
Hathorne, Heather Phone: (205) 638-9568 Email: firstname.lastname@example.org
Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
Bendy, Lisa Phone: (317) 948-7152 Email: email@example.com
The Children's Mercy Hospital (Pediatric and Adult), Kansas City, MO, 64108
Schmoll, Candy Phone: (816) 701-1339 Email: firstname.lastname@example.org
Intermountain Cystic Fibrosis Center (Pediatric), Salt Lake City, UT, 84132
Vroom, Jane Phone: (801) 587-7458 Email: email@example.com