CFF - VX-770 in People with CF and G551D Mutation - Open Label Safety Study (PERSIST)

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Clinical Research Information Sheet

Study Name:

VX-770 in People with CF and G551D Mutation - Open Label Safety Study (PERSIST)

Study Type:

Interventional

Intervention Category:

CFTR Modulation

Study Sponsor:

Vertex

Study Phase:

Recruitment Status:

Trial Completed

Study Drug(s):

Kalydeco

Number of Participants Being Recruited:

110

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

Cystic Fibrosis (CF) is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The CFTR protein is located on the cell membrane of the airways and sweat ducts. It is a chloride ion channel responsible for aiding in the regulation of salt and water absorption and secretion in tissues. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel. The increase in CFTR chloride ion channel opening may prevent hyperabsorption of water in the airway tissues, allowing for more favorable maintenance of airway hydration in people with CF.

This study will look at the long-term safety of VX-770 in people with CF and the G551D mutation. Subjects will receive VX-770 for 96 weeks during this study.

ELIGIBILITY

Age:	>= 6 Years
FEV1:	Not Applicable
P. aeruginosa status:	Not applicable
B. cepacia status:	Not applicable
Other Primary Eligibility Requirements: To be included in this open-label extension study, a subject must have completed either VX-770-102 (STRIVE) or VX-770-103 (ENVISION).
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://www.clinicaltrials.gov/ct2/show/NCT01117012?term=vertex+and+cystic+fibrosis&rank=5

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

Kaiser Permanente Medical Care Program (Pediatric), Oakland, CA, 94611
Contact Information:
    Lee, Julie
    Phone: (510) 752-7558
    Email: julie.lee@kp.org
Stanford University Medical Center (Pediatric), Palo Alto, CA, 94304
Contact Information:
    Dunn, Colleen
    Phone: (650) 736-0388
    Email: cedunn@stanford.edu
Rady Children's Hospital San Diego and Health Center at the University of California San Diego (Pediatric), San Diego, CA, 92123
Contact Information:
    Holland, Sarah
    Phone: (858) 966-8153
    Email: sholland@rchsd.org

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

Emory University (Pediatric), Atlanta, GA, 30322
Contact Information:
    Hunter, Eric
    Phone: (404) 727-9960
    Email: eahunte@emory.edu

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

Saint Luke's Cystic Fibrosis Center of Idaho (Pediatric), Boise, ID, 83712
Contact Information:
    Durham, Dixie
    Phone: (208) 381-7334
    Email: durhamd@slhs.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

Indiana University (Adult), Indianapolis, IN, 46202
Contact Information:
    Richardson, Stacey
    Phone: (317) 948-7121
    Email: stlyrich@iupui.edu
Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
Contact Information:
    Richardson, Stacey
    Phone: (317) 948-7121
    Email: stlyrich@iupui.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

The Minnesota Cystic Fibrosis Center (Pediatric), Minneapolis, MN, 55455
Contact Information:
    Grover, Patricia
    Phone: (612) 626-7425
    Email: Grove026@umn.edu

The Children's Mercy Hospital (Pediatric and Adult), Kansas City, MO, 64108
Contact Information:
    Schmoll, Candy
    Phone: (816) 701-1339
    Email: cschmoll@cmh.edu
Washington University School of Medicine (Adult), St. Louis, MO, 63110
Contact Information:
    Burks, Patricia
    Phone: (314) 454-5175
    Email: Burks_P@kids.wustl.edu

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

Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
Contact Information:
    Marra, Bridget
    Phone: (732) 222-4474
    Email: bmarra@sbhcs.com

Children's Hospital of Buffalo (Pediatric), Buffalo, NY, 14222
Contact Information:
    Caci, Nadine
    Phone: (716) 878-7524
    Email: ncaci@upa.chob.edu
Long Island Jewish Medical Center Adult Program (Adult), New Hyde Park, NY, 11040
Contact Information:
    Wann, Li-Chen
    Phone: (516) 712-9608
    Email: LCWann@nshs.edu
SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
Contact Information:
    Lindner, Donna
    Phone: (315) 464-7525
    Email: lindnerd@upstate.edu

Cincinnati Children's Hospital Medical Center (Pediatric), Cincinnati, OH, 45229
Contact Information:
    Duan, Lorrie
    Phone: (513) 636-7089
    Email: lorrie.duan@cchmc.org
University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
Contact Information:
    Ksenich, Roberta (Bobbi)
    Phone: (216) 844-5733
    Email: Roberta.Ksenich@UHHospitals.org
Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
Contact Information:
    Johnson, Mary Terri
    Phone: (614) 722-4766
    Email: Terri.Johnson@nationwidechildrens.org
Toldeo Children's Hospital (Pediatric), Toledo, OH, 43606
Contact Information:
    Houser, Kelly
    Phone: (419) 291-4630
    Email: kelly.houser@promedica.org

Oregon Health Sciences University (Pediatric), Portland, OR, 97201
Contact Information:
    Andrews-Chavez, Brian
    Phone: (503) 494-6974
    Email: andrewbr@ohsu.edu

Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
Contact Information:
    Kitch, Diane
    Phone: (717) 531-5646
    Email: dkitch@psu.edu
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
Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
Contact Information:
    Hartigan, Elizabeth
    Phone: (412) 692-7060
    Email: elizabeth.hartigan@chp.edu

Vanderbilt University Medical Center (Adult), Nashville, TN, 37232
Contact Information:
    Robinette, Michelle
    Phone: (615) 343-9025
    Email: michelle.robinette@vanderbilt.edu

Intermountain Cystic Fibrosis Center (Pediatric), Salt Lake City, UT, 84132
Contact Information:
    Vroom, Jane
    Phone: (801) 587-7458
    Email: jane.vroom@hsc.utah.edu

University of Virginia (Pediatric), Charlottesville, VA, 22908
Contact Information:
    Moss, Patricia
    Phone: (434) 243-2876
    Email: pcm2v@virginia.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 Washington Medical Center (Adult), Seattle, WA, 98195
Contact Information:
    Wolfstone, Alycia
    Phone: (206) 685-3995
    Email: aewolf@u.washington.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