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Study Name: Ivacaftor Open Label Follow on Study in People with CF who have a Non-G551D CFTR Mutation (112)
Study Type: Interventional
Intervention Category: CFTR Modulation
Study Sponsor: Vertex
Study Phase: 3
Recruitment Status: Recruiting
Study Drug(s): Kalydeco
Number of Participants Being Recruited: 90
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this trial is to look at the safety of long - term ivacaftor treatment in people with CF who have a non-G551D CFTR mutation. Participants in this trial must have previously been in the Ivacaftor in People with CF who have the R117H CFTR mutation trial or in the Ivacaftor in People with CF who have a non-G551D gating mutation trial.
ELIGIBILITY
Age: >= 6 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Participation in either VX-770-110 or VX-770-111. To be eligble for the treatment arm eligible subjects must have completed treatment in either study. To be eligible for the observation arm, subjects must have completed at least 4 weeks of treatment in either VX-770-110 or VX-770-111.
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/show/NCT01707290
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.
CA
  • 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
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
GA
  • Emory University (Pediatric), Atlanta, GA, 30322
    Contact Information:
        Hunter, Eric
        Phone: (404) 785-3102
        Email: eahunte@emory.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
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 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:
        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
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
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
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
  • 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
  • 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
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
  • University of Texas Southwestern Medical Center/ St. Paul University Hospital (Adult), Dallas, TX, 75390
    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
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 and Adult), Richmond, VA, 23235
    Contact Information:
        Ward, Matthew
        Phone: (804) 628-3093
        Email: wardmt@vcu.edu
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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