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Study Name: Ivacaftor in People with CF who have the R117H-CFTR mutation (KONDUCT)(110)
Study Type: Interventional
Intervention Category: CFTR Modulation
Study Sponsor: Vertex
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Kalydeco
Number of Participants Being Recruited: 70
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
Ivacaftor ( Trade Name Kalydeco) is the first cystic fibrosis transmembrane regulator (CFTR) modulator to show an improvement in CFTR function and clinical benefit in people with CF. Ivacaftor was initially approved in the United States for the treatment of CF in patients 6 years of age and older who have a G551D mutation in the CFTR gene. This study will look at the safety and effectiveness of ivcaftor in people with CF age 6 years and older who have the R117H mutation. Study participants will be on the study drug or placebo for 24 weeks.
ELIGIBILITY
Age: >= 6 Years
FEV1: 40 - 105 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Eligible patients must have the R117H mutation on at least one 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
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT01614457
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.
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
CA
  • Stanford University Medical Center (Pediatric), Palo Alto, CA, 94304
    Contact Information:
        Dunn, Colleen
        Phone: (650) 736-0388
        Email: cedunn@stanford.edu
CT
  • Central Connecticut Cystic Fibrosis Center (Pediatric), Hartford, CT, 06102
    Contact Information:
        Drapeau, Ginny
        Phone: (860) 545-9434
        Email: gdrapea@connecticutchildrens.org
FL
  • Tampa General Hospital (Adult), Tampa, FL, 33606
    Contact Information:
        Roberson, Suzanne
        Phone: (813) 844-7179
        Email: sroberson@tgh.org
IA
  • University of Iowa (Pediatric), Iowa City, IA, 52242
    Contact Information:
        Teresi, Mary
        Phone: (319) 384-7546
        Email: mary-teresi@uiowa.edu
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
KY
  • University of Kentucky (Pediatric), Lexington, KY, 40536
    Contact Information:
        Watts, Tammy
        Phone: (859) 257-5087
        Email: Tammy.watts@uky.edu
MA
  • Children's Hospital Boston (Pediatric), Boston, MA, 02115
    Contact Information:
        Fowler, Robert
        Phone: (617) 355-1834
        Email: Robert.fowler@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 Adult CF Program (Adult), Baltimore, MD, 21205
    Contact Information:
        Callahan, Karen
        Phone: (443) 287-8983
        Email: kcallah1@jhmi.edu
MI
  • Children's Hospital of Michigan (Pediatric), 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:
        Gile, Cynthia
        Phone: (616) 391-6148
        Email: Cynthia.Gile@spectrumhealth.org
MO
  • Washington University School of Medicine (Adult), St. Louis, MO, 63110
    Contact Information:
        Burks, Patricia
        Phone: (314) 454-5175
        Email: Burks_P@kids.wustl.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
NE
  • University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
    Contact Information:
        Telfer, Raquel
        Phone: (402) 559-6275
        Email: raquel.telfer@unmc.edu
  • University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
    Contact Information:
        Acquazzino, Diane
        Phone: (402) 559-6275
        Email: dracquaz@unmc.edu
NY
  • Beth Israel Medical Center (Pediatric), New York, NY, 10003
    Contact Information:
        DiBenedetto, Donna
        Phone: (212) 420-4100
        Email: ddibenedetto@chpnet.org
  • Beth Israel Medical Center (Pediatric), New York, NY, 10003
    Contact Information:
        Grece, Carroll Anne
        Phone: (212) 420-4196
        Email: cgrece@chpnet.org
  • 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
  • Children's Hospital of New York Columbia University (Pediatric), New York City, NY, 10032
    Contact Information:
        Sadeghi, Hossein
        Phone: (212) 305-5122
        Email: hs762@cumc.columbia.edu
  • New York Medical College/Westchester Medical Center (Pediatric), Valhalla, NY, 10595
    Contact Information:
        Gherson, Ingrid
        Phone: (914) 594-2348
        Email: ingrid_gherson@nymc.edu
PA
  • University of Pennsylvania Hospital (Adult), Philadelphia, PA, 19104
    Contact Information:
        Kubrak, Christina
        Phone: (267) 426-5135
        Email: kubrak@email.chop.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
TN
  • 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
  • University of Texas Southwestern Medical Center/ St. Paul University Hospital (Adult), Dallas, TX, 75390
    Contact Information:
        Keller, Ashley
        Phone: (214) 648-2817
        Email: Ashley.Keller@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 (Adult), Salt Lake City, UT, 84132
    Contact Information:
        Packer, Kristyn
        Phone: (801) 585-0401
        Email: kristyn.packer@hsc.utah.edu
VA
  • Virginia Commonwealth University (Pediatric), Richmond, VA, 23235
    Contact Information:
        Ward, Matthew
        Phone: (804) 628-3093
        Email: wardmt@vcu.edu
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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