CFF - Ivacaftor (Kalydeco) in People with CF who have the R117H-CFTR mutation (KONDUCT)

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Clinical Research Information Sheet

Study Name:

Ivacaftor (Kalydeco) in People with CF who have the R117H-CFTR mutation (KONDUCT)

Study Type:

Interventional

Intervention Category:

CFTR Modulation

Study Sponsor:

Vertex

Study Phase:

Recruitment Status:

Recruiting

Study Drug(s):

Kalydeco

Number of Participants Being Recruited:

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.

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

Stanford University Medical Center (Pediatric), Palo Alto, CA, 94304
Contact Information:
    Dunn, Colleen
    Phone: (650) 736-0388
    Email: cedunn@stanford.edu

Central Connecticut Cystic Fibrosis Center (Pediatric), Hartford, CT, 06102
Contact Information:
    Drapeau, Ginny
    Phone: (860) 545-9434
    Email: gdrapea@ccmckids.org

University of Iowa (Pediatric), Iowa City, IA, 52242
Contact Information:
    Teresi, Mary
    Phone: (319) 384-7546
    Email: mary-teresi@uiowa.edu

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 Kentucky (Pediatric), Lexington, KY, 40536
Contact Information:
    Watts, Tammy
    Phone: (859) 257-5087
    Email: twatt2@uky.edu

Children's Hospital Boston (Pediatric), Boston, MA, 02115
Contact Information:
McGeachey, Amanda
Email: amanda.mcgeachey@childrens.harvard.edu
Massachusetts General Hospital (Pediatric), Boston, MA, 02114
Contact Information:
    Doolittle, Caitlin
    Phone: (617) 726-3719
    Email: cdoolittle1@partners.org

Johns Hopkins Adult CF Program (Adult), Baltimore, MD, 21205
Contact Information:
    Callahan, Karen
    Phone: (443) 287-8983
    Email: kcallah1@jhmi.edu

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:
    Symington, Thomas
    Phone: (616) 391-9366
    Email: thomas.symington@spectrumhealth.org

University of North Carolina at Chapel Hill (Pediatric), Chapel Hill, NC, 27599
Contact Information:
    Stephenson, Kelly
    Phone: (919) 843-7121
    Email: kelly.stephenson@unc.edu

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

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
SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
Contact Information:
    Lindner, Donna
    Phone: (315) 464-7525
    Email: lindnerd@upstate.edu
New York Medical College/Westchester Medical Center (Pediatric), Valhalla, NY, 10595
Contact Information:
    Gherson, Ingrid
    Phone: (914) 594-3320
    Email: ingrid_gherson@nymc.edu

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

Medical University of South Carolina (Adult), Charleston, SC, 29425
Contact Information:
    Warden, Ashley
    Phone: (843) 792-4349
    Email: jonesash@musc.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

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
Children's Medical Center of Dallas (Pediatric), Dallas, TX, 75235
Contact Information:
    Hebert, Andrew
    Phone: (214) 456-5618
    Email: andrew.hebert@childrens.com
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

Intermountain Cystic Fibrosis Center (Adult), Salt Lake City, UT, 84132
Contact Information:
    Packer, Kristyn
    Phone: (801) 585-0401
    Email: kristyn.packer@hsc.utah.edu

Virginia Commonwealth University (Pediatric), Richmond, VA, 23235
Contact Information:
    Ward, Matthew
    Phone: (804) 628-3093
    Email: wardmt@vcu.edu

Seattle Children's Hospital (Pediatric), Seattle, WA, 98105
Contact Information:
    McNamara, Sharon
    Phone: (206) 987-3921 X1
    Email: sharon.mcnamara@seattlechildrens.org

University of Wisconsin (Adult), Madison, WI, 53792
Contact Information:
    Stevens, Chiron (Sophia)
    Phone: (608) 263-1244
    Email: scstevens@medicine.wisc.edu

West Virginia University CF Center (Pediatric and Adult), Morgantown, WV, 26505
Contact Information:
    Collins, Sue
    Phone: (304) 293-7348
    Email: scollins@hsc.wvu.edu