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Study Name: Vertex Lumacaftor (VX-809) and ivacaftor in people with CF who are aged 12 years and have two copies of the delF508 CFTR mutation (TRAFFIC)(103)
Study Type: Interventional
Intervention Category: CFTR Modulation
Study Sponsor: Vertex
Study Phase: 3
Recruitment Status: Recruiting Completed
Study Drug(s): VX-809/VX-770
Number of Participants Being Recruited: 498
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This is the first of the two Phase 3, randomized, double-blind, placebo-controlled, parallel group multi-center trials looking at the safety and effectiveness of VX 809 taken in combination with ivacaftor in people with CF who are aged 12 years and older and have two copies of the F508del-CFTR mutation. Participants will be in the study for 28 weeks +/- 7 days. Specimens of blood and urine will be collected along with pulmonary function and other testing.
ELIGIBILITY
Age: >= 12 Years
FEV1: >= 40 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Negative
Other Primary Eligibility Requirements:

Eligible subjects must be homozygous for the DF508 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.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01807923
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
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.
AK
  • Providence Alaska Medical Center (Pediatric and Adult), Anchorage, AK, 99508
    Contact Information:
        Roberts, Vicki
        Phone: (907) 212-3299
        Email: vicki.roberts@providence.org
AL
  • The Children's Hospital/University of Alabama at Birmingham (Pediatric), Birmingham, AL, 35233
    Contact Information:
        Hathorne, Heather
        Phone: (205) 638-9568
        Email: hhathorne@peds.uab.edu
AR
  • Arkansas Children's Hospital (Pediatric), Little Rock, AR, 72202
    Contact Information:
        Ramsey, Lacey LeAnn
        Phone: (501) 364-2391
        Email: LRamsey@uams.edu
AZ
  • Tucson CF Center (Pediatric and Adult), Tucson, AZ, 85724
    Contact Information:
        Molina de Rodriguez, Osmara
        Phone: (520) 891-6767
        Email: omolina@email.arizona.edu
CA
  • Miller Children's Hospital (Pediatric), Long Beach, CA, 90801
    Contact Information:
        O'Donnell, Nan
        Phone: (562) 933-5607
        Email: nodonnell@memorialcare.org
  • Children's Hospital of Los Angeles (Pediatric), Los Angeles, CA, 90027
    Contact Information:
        Marquez, Gonzalo
        Phone: (323) 361-5251
        Email: gmarquez@chla.usc.edu
  • USC Keck School of Medicine (Adult), Los Angeles, CA, 90033
    Contact Information:
        Fukushima, Lynn
        Phone: (323) 442-5869
        Email: lynn.fukushima@med.usc.edu
  • Kaiser Permanente Medical Care Program (Pediatric), Oakland, CA, 94611
    Contact Information:
        Lee, Julie
        Phone: (510) 752-7558
        Email: julie.lee@kp.org
  • Stanford University Medical Center (Pediatric), Palo Alto, CA, 94304
    Contact Information:
        Dunn, Colleen
        Phone: (650) 736-0388
        Email: cedunn@stanford.edu
CO
  • National Jewish Health (Adult), Denver, CO, 80206
    Contact Information:
        Jones, Marion
        Phone: (303) 398-1265
        Email: jonesm@njhealth.org
FL
  • University of Florida (Adult), Gainesville, FL, 32610
    Contact Information:
        Nichols, Wanda
        Phone: (352) 273-8732
        Email: nichowj@medicine.ufl.edu
  • Tampa General Hospital (Adult), Tampa, FL, 33606
    Contact Information:
        Roberson, Suzanne
        Phone: (813) 844-7179
        Email: sroberson@tgh.org
GA
  • Emory University (Pediatric), Atlanta, GA, 30322
    Contact Information:
        Hunter, Eric
        Phone: (404) 785-3102
        Email: eahunte@emory.edu
ID
  • Saint Luke's Cystic Fibrosis Center of Idaho (Pediatric), Boise, ID, 83712
    Contact Information:
        Durham, Dixie
        Phone: (208) 381-7334
        Email: durhamd@slhs.org
IL
  • Ann and Robert H. Lurie Children's Hospital of Chicago (Pediatric), Chicago, IL, 60611
    Contact Information:
        Singh, Noopur
        Phone: (312) 227-6861
        Email: nosingh@luriechildrens.org
  • University of Chicago (Pediatric), Chicago, IL, 60637
    Contact Information:
        Cheatham, Jeannine
        Phone: (773) 834-0192
        Email: jcheatham@peds.bsd.uchicago.edu
MA
  • Children's Hospital Boston (Pediatric), Boston, MA, 02115
    Contact Information:
        Correia, Catherine
        Phone: (617) 355-2446
        Email: Catherine.Correia@childrens.harvard.edu
  • Massachusetts General Hospital (Pediatric), Boston, MA, 02114
    Contact Information:
        Doolittle, Caitlin
        Phone: (617) 726-3719
        Email: cdoolittle1@partners.org
MD
  • Johns Hopkins University (Pediatric), Baltimore, MD, 21287
    Contact Information:
        Callahan, Karen
        Phone: (443) 287-8983
        Email: kcallah1@jhmi.edu
MI
  • University of Michigan Health System (Pediatric), Ann Arbor, MI, 48109
    Contact Information:
        Kruse, Dawn
        Phone: (734) 615-3266
        Email: dmkruse@umich.edu
MO
  • The Children's Mercy Hospital (Pediatric and Adult), Kansas City, MO, 64108
    Contact Information:
        Schmoll, Candy
        Phone: (816) 701-1339
        Email: cschmoll@cmh.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
  • Duke University Medical Center (Pediatric), Durham, NC, 27710
    Contact Information:
        West, Miranda
        Phone: (919) 684-2281
        Email: miranda.west@duke.edu
NH
  • Dartmouth Hitchcock Medical Center (Pediatric), Lebanon, NH, 03756
    Contact Information:
        Moulton, Lisa
        Phone: (603) 650-8178
        Email: Lisa.A.Moulton@Hitchcock.ORG
NJ
  • Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
    Contact Information:
        Marra, Bridget
        Phone: (732) 222-4474
        Email: bmarra@barnabashealth.org
NY
  • Beth Israel Medical Center (Pediatric), New York, NY, 10003
    Contact Information:
        Grece, Carroll Anne
        Phone: (212) 420-4196
        Email: cgrece@chpnet.org
  • Beth Israel Medical Center (Pediatric), New York, NY, 10003
    Contact Information:
        DiBenedetto, Donna
        Phone: (212) 420-4100
        Email: ddibenedetto@chpnet.org
  • New York Medical College/Westchester Medical Center (Pediatric), Valhalla, NY, 10595
    Contact Information:
        Gherson, Ingrid
        Phone: (914) 594-2348
        Email: ingrid_gherson@nymc.edu
OH
  • Children's Hospital Medical Center of Akron (Pediatric), Akron, OH, 44308
    Contact Information:
        Ouellette, Deborah
        Phone: (330) 543-3089
        Email: douellette@chmca.org
  • Cincinnati Children's Hospital Medical Center (Pediatric), Cincinnati, OH, 45229
    Contact Information:
        Duan, Lorrie
        Phone: (513) 636-7089
        Email: lorrie.duan@cchmc.org
  • Dayton Children's Hospital (Pediatric), Dayton, OH, 45404
    Contact Information:
        Bartosik, Sandy
        Phone: (937) 641-4004
        Email: bartosiks@childrensdayton.org
OR
  • Oregon Health Sciences University (Pediatric), Portland, OR, 97201
    Contact Information:
        Simmons, Kim
        Phone: (503) 494-7807
        Email: simmonsk@ohsu.edu
PA
  • Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
    Contact Information:
        Kitch, Diane
        Phone: (717) 531-5646
        Email: dkitch@psu.edu
TX
  • Dell Children's Medical Center of Central Texas (Pediatric and Adult), Austin, TX, 78723
    Contact Information:
        Brazil, Isolde
        Phone: (512) 380-9200 X65343
        Email: IBrazil@seton.org
VA
  • University of Virginia (Pediatric), Charlottesville, VA, 22908
    Contact Information:
        Moss, Patricia
        Phone: (434) 243-2876
        Email: pcm2v@virginia.edu
VT
  • Vermont Children's Hospital (Pediatric), Burlington, VT, 05401
    Contact Information:
        Lippmann, Joan
        Phone: (802) 847-6982
        Email: joan.lippmann@vtmednet.org
WA
  • Seattle Children's Hospital (Pediatric), Seattle, WA, 98105
    Contact Information:
        McNamara, Sharon
        Phone: (206) 987-3921 X1
        Email: sharon.mcnamara@seattlechildrens.org
WI
  • University of Wisconsin (Adult), Madison, WI, 53792
    Contact Information:
        Stevens, Chiron (Sophia)
        Phone: (608) 263-1244
        Email: scstevens@medicine.wisc.edu
WV
  • West Virginia University CF Center (Pediatric and Adult), Morgantown, WV, 26505
    Contact Information:
        Collins, Sue
        Phone: (304) 293-7348
        Email: scollins@hsc.wvu.edu
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