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Study Name: Vertex Lumacaftor (VX-809) and Ivacaftor in People with CF aged 12 years and older and have two copies of the delF508 CFTR mutation (TRANSPORT)(104)
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: 490
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This is the second of the two nearly identical 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 DeltaF508 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/NCT01807949
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.
CO
  • Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
    Contact Information:
        Pardee, Churee
        Phone: (720) 777-6162
        Email: churee.pardee@childrenscolorado.org
CT
  • Central Connecticut Cystic Fibrosis Center (Pediatric), Hartford, CT, 06102
    Contact Information:
        Drapeau, Ginny
        Phone: (860) 545-9434
        Email: gdrapea@connecticutchildrens.org
  • Yale University School of Medicine (Pediatric), New Haven, CT, 06520
    Contact Information:
        Young, Jane
        Phone: (203) 785-5852
        Email: jane.young@yale.edu
DE
  • Alfred I. duPont Hospital for Children (Pediatric and Adult), Wilmington, DE, 19899
    Contact Information:
        Budd, Sandra
        Phone: (302) 651-6536
        Email: sbudd@nemours.org
FL
  • Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
    Contact Information:
        DeLuca, Elizabeth
        Phone: (904) 697-3804
        Email: Elizabeth.DeLuca@nemours.org
  • University of Miami (Pediatric), Miami, FL, 33136
    Contact Information:
        Mendes, Eliana
        Phone: (305) 243-2568
        Email: emendes@med.miami.edu
IA
  • University of Iowa (Pediatric), Iowa City, IA, 52242
    Contact Information:
        Teresi, Mary
        Phone: (319) 384-7546
        Email: mary-teresi@uiowa.edu
IN
  • Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
    Contact Information:
        Bendy, Lisa
        Phone: (317) 948-7152
        Email: lbendy@iupui.edu
KS
  • University of Kansas Medical Center (Pediatric), Kansas City, KS, 66160
    Contact Information:
        Liebergen, Adrienne
        Phone: (913) 588-6320
        Email: alieberg@kumc.edu
KY
  • University of Kentucky (Pediatric), Lexington, KY, 40536
    Contact Information:
        Watts, Tammy
        Phone: (859) 257-5087
        Email: twatt2@uky.edu
MA
  • University of Massachusetts Memorial Health Care (Pediatric), Worcester, MA, 01655
    Contact Information:
        Longtine, Karen
        Phone: (508) 856-6970
        Email: Karen.Longtine@umassmed.edu
ME
  • Maine Medical Partners Pediatric Specialty Care (Pediatric), Portland, ME, 04102
    Contact Information:
        Milliard, Carrie
        Phone: (207) 662-6712
        Email: millic@mmc.org
MI
  • Wayne State University Harper University Hospital (Adult), Detroit, MI, 48201
    Contact Information:
        Van Wagnen, Catherine
        Phone: (313) 745-4737
        Email: cvanwag@med.wayne.edu
  • Helen DeVos Women and Children's Center (Pediatric), Grand Rapids, MI, 49503
    Contact Information:
        Symington, Thomas
        Phone: (616) 391-9366
        Email: thomas.symington@spectrumhealth.org
MN
  • Children's Hospitals and Clinics (Pediatric), Minneapolis, MN, 55404
    Contact Information:
        Johnson, Mahrya
        Phone: (612) 813-6384
        Email: mahrya.johnson@childrensmn.org
  • The Minnesota Cystic Fibrosis Center (Adult), Minneapolis, MN, 55455
    Contact Information:
        Grover, Patricia
        Phone: (612) 626-7425
        Email: Grove026@umn.edu
MO
  • Cardinal Glennon Children's Medical Center (St. Louis University) (Pediatric), St. Louis, MO, 63104
    Contact Information:
        Cooper, Amy
        Phone: (314) 678-5457
        Email: acoope16@slu.edu
  • Washington University School of Medicine (Adult), St. Louis, MO, 63110
    Contact Information:
        Burks, Patricia
        Phone: (314) 454-5175
        Email: Burks_P@kids.wustl.edu
MS
  • University of Mississippi Medical Center (Pediatric), Jackson, MS, 39216
    Contact Information:
        Adcock, Kim
        Phone: (601) 815-9172
        Email: kadcock@umc.edu
NE
  • University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
    Contact Information:
        Acquazzino, Diane
        Phone: (402) 559-6275
        Email: dracquaz@unmc.edu
  • University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
    Contact Information:
        Telfer, Raquel
        Phone: (402) 559-6275
        Email: raquel.telfer@unmc.edu
NJ
  • Bristol-Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital (Pediatric), New Brunswick, NJ, 09801
    Contact Information:
        Cerracchio, Lisa
        Phone: (732) 235-6050
        Email: lisa.cerracchio@rutgers.edu
NY
  • Albany Medical College (Pediatric), Albany, NY, 12208
    Contact Information:
        Evans, Terese
        Phone: (518) 262-5293
        Email: evansmt@mail.amc.edu
  • Women and Children's Hospital of Buffalo (Pediatric), Buffalo, NY, 14222
    Contact Information:
        Caci, Nadine
        Phone: (716) 878-7524
        Email: ncaci@upa.chob.edu
  • Children's Hospital of New York Columbia University (Pediatric), New York City, NY, 10032
    Contact Information:
        Kattan, Meyer
        Phone: (212) 305-5122
        Email: mk2833@columbia.edu
  • University of Rochester Medical Center Strong Memorial (Pediatric), Rochester, NY, 14642
    Contact Information:
        Nix, Nancy
        Phone: (585) 275-8580
        Email: Nancy_Nix@URMC.Rochester.edu
  • SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
    Contact Information:
        Lindner, Donna
        Phone: (315) 464-7525
        Email: lindnerd@upstate.edu
OH
  • University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
    Contact Information:
        Ksenich, Roberta (Bobbi)
        Phone: (216) 844-5733
        Email: Roberta.Ksenich@UHHospitals.org
  • Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
    Contact Information:
        Gilmore, Diana
        Phone: (614) 722-4752
        Email: Diana.Gilmore@nationwidechildrens.org
  • Toldeo Children's Hospital (Pediatric), Toledo, OH, 43606
    Contact Information:
        Houser, Kelly
        Phone: (419) 291-4630
        Email: kelly.houser@promedica.org
OK
  • Oklahoma Cystic Fibrosis Center (Pediatric), Oklahoma City, OK, 73104
    Contact Information:
        Fox, Jodie
        Phone: (405) 271-6216
        Email: Jodie-Fox@ouhsc.edu
PA
  • Children's Hospital of Philadelphia University of Pennsylvania (Pediatric), Philadelphia, PA, 19104
    Contact Information:
        Kubrak, Christina
        Phone: (267) 426-5135
        Email: kubrak@email.chop.edu
  • Drexel University College of Medicine (Adult), Philadelphia, PA, 19129
    Contact Information:
        Hillman, Judy
        Phone: (215) 762-5462
        Email: jhillman@drexelmed.edu
  • St. Christopher's Hospital for Children (Pediatric), Philadelphia, PA, 19134
    Contact Information:
        Fritsch, Jacqueline
        Phone: (215) 427-3816
        Email: jacqueline.fritsch@drexelmed.edu
  • Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
    Contact Information:
        Hartigan, Elizabeth
        Phone: (412) 692-7060
        Email: elizabeth.hartigan@chp.edu
SC
  • Medical University of South Carolina (Adult), Charleston, SC, 29425
    Contact Information:
        Warden, Ashley
        Phone: (843) 792-4349
        Email: jonesash@musc.edu
SD
  • Sanford Medical Center (Pediatric), Sioux Falls, SD, 57117
    Contact Information:
        Sandman, Carmen
        Phone: (605) 312-0008
        Email: Carmen.Sandman@SanfordHealth.org
TN
  • University of Tennessee CF Care and Research Center (Pediatric), Memphis, TN, 38103
    Contact Information:
        Culbreath, Barbara
        Phone: (901) 287-5351
        Email: bculbreath@uthsc.edu
  • Vanderbilt Children's Hospital Vanderbilt University Medical Center (Pediatric), Nashville, TN, 37232
    Contact Information:
        Berry, Pamela
        Phone: (615) 936-8308
        Email: pamela.berry@Vanderbilt.Edu
TX
  • Children's Medical Center of Dallas (Pediatric), Dallas, TX, 75235
    Contact Information:
        Hebert, Andrew
        Phone: (214) 456-5618
        Email: andrew.hebert@childrens.com
  • Children's Medical Center of Dallas (Pediatric), Dallas, TX, 75235
    Contact Information:
        Dunn-Richmond, Kate
        Phone: (214) 648-2817
        Email: Kate.dunn-richmond@utsouthwestern.edu
  • Cook Children's Medical Center (Pediatric), Fort Worth, TX, 76104
    Contact Information:
        Morris, Trudy
        Phone: (682) 885-1244
        Email: Trudy.Morris@cookchildrens.org
  • Baylor College of Medicine (Pediatric), Houston, TX, 77030
    Contact Information:
        Schaap, Nicoline
        Phone: (832) 822-4252
        Email: nxschaap@texaschildrens.org
UT
  • Intermountain Cystic Fibrosis Center (Pediatric), Salt Lake City, UT, 84132
    Contact Information:
        Vroom, Jane
        Phone: (801) 587-7458
        Email: jane.vroom@hsc.utah.edu
VA
  • Virginia Commonwealth University (Pediatric and Adult), Richmond, VA, 23235
    Contact Information:
        Ward, Matthew
        Phone: (804) 628-3093
        Email: wardmt@vcu.edu
WA
  • University of Washington Medical Center (Adult), Seattle, WA, 98195
    Contact Information:
        Aitken, Moira
        Phone: (206) 543-3166
        Email: moira@u.washington.edu
WI
  • Children's Hospital of Wisconsin Froedtert & Medical College of Wisconsin (Pediatric), Milwaukee, WI, 53201
    Contact Information:
        Kump, Theresa
        Phone: (414) 337-7144
        Email: tkump@mcw.edu
  • Froedtert & Medical College of Wisconsin (Adult), Milwaukee, WI, 53201
    Contact Information:
        Harris, Rachel
        Phone: (414) 955-7030
        Email: racharris@mcw.edu
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