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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
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).
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 If a specific trial listing for this trial is available, a link to the specific listing will be present in the "More Information" section below.
Sponsor Contact Information: Medical Monitor, Vertex
(617) 444-6777
Trial Specific Link on
Clinical Research Terms Glossary: Click here
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.
  • Tampa General Hospital (Adult), Tampa, FL, 33606
    Contact Information:
        Roberson, Suzanne
        Phone: (813) 844-7179
  • Emory University (Pediatric), Atlanta, GA, 30322
    Contact Information:
        Hunter, Eric
        Phone: (404) 785-3102
  • Ann and Robert H. Lurie Children's Hospital of Chicago (Pediatric), Chicago, IL, 60611
    Contact Information:
        Singh, Noopur
        Phone: (312) 227-6861
  • Children's Hospital Boston (Pediatric), Boston, MA, 02115
    Contact Information:
        Fowler, Robert
        Phone: (617) 355-1834
  • University of Michigan Health System (Pediatric), Ann Arbor, MI, 48109
    Contact Information:
        Kruse, Dawn
        Phone: (734) 615-3266
  • Children's Hospitals and Clinics (Pediatric), Minneapolis, MN, 55404
    Contact Information:
        Johnson, Mahrya
        Phone: (612) 813-6384
  • Washington University School of Medicine (Adult), St. Louis, MO, 63110
    Contact Information:
        Burks, Patricia
        Phone: (314) 454-5175
  • Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
    Contact Information:
        Hartigan, Elizabeth
        Phone: (412) 692-7060
  • Baylor College of Medicine (Pediatric), Houston, TX, 77030
    Contact Information:
        Schaap, Nicoline
        Phone: (832) 822-4252
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