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Study Name: Ivacaftor in People with CF who have a Non G551D Gating Mutation (KONNECTION) (111)
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: 40
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
Ivacaftor (Trade Name Kalydeco) is the first CFTR modulator to show an improvement in CFTR function and clinical benefit in patients with CF. Ivacaftor was initially approved in the United States for the treatment of CF in people 6 years of age and older who have a G551D mutation in the CFTR gene. This trial will look at the safety and effectiveness of ivacaftor in people with CF who are 6 years of age and older and have a non G551D gating mutation (any 1 of the following: G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D).
ELIGIBILITY
Age: >= 6 Years
FEV1: 40 - 105 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Eligible subjects must have at least 1 allele of the following CFTR gating mutations: G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, G1349. Eligible subjects cannot have the G551 mutation in either 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/NCT01614470
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.
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:
        Fowler, Robert
        Phone: (617) 355-1834
        Email: Robert.fowler@childrens.harvard.edu
MI
  • University of Michigan Health System (Pediatric), Ann Arbor, MI, 48109
    Contact Information:
        Kruse, Dawn
        Phone: (734) 615-3266
        Email: dmkruse@umich.edu
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
PA
  • Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
    Contact Information:
        Hartigan, Elizabeth
        Phone: (412) 692-7060
        Email: elizabeth.hartigan@chp.edu
TX
  • Baylor College of Medicine (Pediatric), Houston, TX, 77030
    Contact Information:
        Schaap, Nicoline
        Phone: (832) 822-4252
        Email: nxschaap@texaschildrens.org
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