Vertex 770 - a phase 2 trial evaluating the effect of VX- 770 on Lung Clearance Index (VX 770-106)
Study Type:
Interventional
Intervention Category:
CFTR Modulation
Study Sponsor:
Vertex
Study Phase:
2
Recruitment Status:
Trial Completed
Study Drug(s):
Kalydeco
Number of Participants Being Recruited:
24
Single / Multi-Center:
Multi-Center
STUDY BACKGROUND INFORMATION:
This is a randomized, double blind, placebo controlled, crossover study to look at the effect of VX 770 on the lung clearance index of people with CF who have the G551D mutation, an FEV1 > 90%, and are 6 yrs or older. A study participant will be first randomly assigned to the placebo or study drug, VX 770, to take orally two times a day for a 28 day period and then "crossover" to the placebo or study drug they had not taken originally. The lung clearance index will be measured at study visits. The lung clearance index will measure lung function to determine if there are any lung changes.
ELIGIBILITY
Age:
>= 6 Years
FEV1:
>= 90 Percent Predicted
P. aeruginosa status:
Not applicable
B. cepacia status:
Negative
Other Primary Eligibility Requirements:
To be included in this study patients must have the G551D-CFTR mutation in at least 1 allele (any known or unknown mutations allowed in second allele).
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.
FOR MORE INFORMATION:
Sponsor Contact Information:
Medical Monitor, Vertex (617) 444-6777 medicalinfo@vrtx.com
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.
CA
Stanford University Medical Center (Pediatric), Palo Alto, CA, 94304
Contact Information:
Dunn, Colleen Phone: (650) 736-0388 Email: cedunn@stanford.edu
IA
University of Iowa (Pediatric), Iowa City, IA, 52242
Contact Information:
Teresi, Mary Phone: (319) 384-7546 Email: mary-teresi@uiowa.edu
NC
University of North Carolina at Chapel Hill (Pediatric), Chapel Hill, NC, 27599
Contact Information:
Barlow, Carol Phone: (919) 966-9146 Email: cbarlow@med.unc.edu
PA
Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
Contact Information:
Hartigan, Elizabeth Phone: (412) 692-7060 Email: elizabeth.hartigan@chp.edu
