CFF - Ivacaftor Open Label Follow on Study in People with CF who have a Non-G551D CFTR Mutation

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Clinical Research Information Sheet

Study Name:

Ivacaftor Open Label Follow on Study in People with CF who have a Non-G551D CFTR Mutation

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:

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.

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

National Jewish Health (Adult), Denver, CO, 80206
Contact Information:
    Jones, Marion
    Phone: (303) 398-1265
    Email: jonesm@njhealth.org

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

Tampa General Hospital (Adult), Tampa, FL, 33606
Contact Information:
    Roberson, Suzanne
    Phone: (813) 844-7179
    Email: sroberson@tgh.org

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

Children's Hospital Boston (Pediatric), Boston, MA, 02115
Contact Information:
McGeachey, Amanda
Email: amanda.mcgeachey@childrens.harvard.edu

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

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) 594-3320
    Email: ingrid_gherson@nymc.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

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