Study Name: VX-661 (101) alone and in combination with Ivacaftor in People with Cystic Fibrosis and F508del-CFTR mutation
Study Type: Interventional
Intervention Category: CFTR Modulation
Study Sponsor: Vertex
Study Phase: 2
Recruitment Status: Trial Completed
Study Drug(s): VX-661/VX-770
Number of Participants Being Recruited: 200
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This multi-center trial will look at the safety and effectiveness of VX-661, when taken alone and in combination with ivacaftor in people with CF who are 18 years of age and older and have two copies of the F508del-CFTR mutation. Additionally the trial will look at the pharmacological properties of VX-661 in the body - how well the body absorbs, breaks down, and gets rid of the drug. This trial will be separated into three parts. Study participants may only be in one part of the study and may receive placebo or study drug.
ELIGIBILITY
Age: >= 18 Years
FEV1: 40 - 90 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Subjects must have the F508del-CFTR gene mutation in both alleles
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/NCT01531673?term=vertex+661&rank=1
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.
AL
  • 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
CA
  • Kaiser Permanente Medical Care Program (Pediatric), Oakland, CA, 94611
    Contact Information:
        Lee, Julie
        Phone: (510) 752-7558
        Email: julie.lee@kp.org
ID
  • Saint Luke's Cystic Fibrosis Center of Idaho (Pediatric), Boise, ID, 83712
    Contact Information:
        Durham, Dixie
        Phone: (208) 381-7334
        Email: durhamd@slhs.org
IL
  • Northwestern University (Adult), Chicago, IL, 60611
    Contact Information:
        Singh, Noopur
        Phone: (312) 227-6861
        Email: nosingh@luriechildrens.org
MA
  • Massachusetts General Hospital (Pediatric), Boston, MA, 02114
    Contact Information:
        Doolittle, Caitlin
        Phone: (617) 726-3719
        Email: cdoolittle1@partners.org
MI
  • Helen DeVos Women and Children's Center (Pediatric), Grand Rapids, MI, 49503
    Contact Information:
        Gile, Cynthia
        Phone: (616) 391-6148
        Email: Cynthia.Gile@spectrumhealth.org
MO
  • The Children's Mercy Hospital (Pediatric and Adult), Kansas City, MO, 64108
    Contact Information:
        Schmoll, Candy
        Phone: (816) 701-1339
        Email: cschmoll@cmh.edu
NC
  • University of North Carolina at Chapel Hill (Pediatric), Chapel Hill, NC, 27599
    Contact Information:
        Barlow, Carol
        Phone: (919) 966-9146
        Email: cbarlow@med.unc.edu
NJ
  • Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
    Contact Information:
        Marra, Bridget
        Phone: (732) 222-4474
        Email: bmarra@barnabashealth.org
NY
  • 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
OH
  • Cincinnati Children's Hospital Medical Center (Pediatric), Cincinnati, OH, 45229
    Contact Information:
        Decker, Beth
        Phone: (513) 803-4325
        Email: Beth.Decker@cchmc.org
  • Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
    Contact Information:
        Gilmore, Diana
        Phone: (614) 722-4752
        Email: Diana.Gilmore@nationwidechildrens.org
OK
  • Oklahoma Cystic Fibrosis Center (Pediatric), Oklahoma City, OK, 73104
    Contact Information:
        Fox, Jodie
        Phone: (405) 271-6216
        Email: Jodie-Fox@ouhsc.edu
PA
  • 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 Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
    Contact Information:
        Hartigan, Elizabeth
        Phone: (412) 692-7060
        Email: elizabeth.hartigan@chp.edu
SC
  • Medical University of South Carolina (Adult), Charleston, SC, 29425
    Contact Information:
        Warden, Ashley
        Phone: (843) 792-4349
        Email: jonesash@musc.edu
UT
  • Intermountain Cystic Fibrosis Center (Pediatric), Salt Lake City, UT, 84132
    Contact Information:
        Vroom, Jane
        Phone: (801) 587-7458
        Email: jane.vroom@hsc.utah.edu
VT
  • Vermont Children's Hospital (Pediatric), Burlington, VT, 05401
    Contact Information:
        Burns, Stephanie
        Phone: (802) 847-2103
        Email: Stephanie.Burns@vtmednet.org
WA
  • University of Washington Medical Center (Adult), Seattle, WA, 98195
    Contact Information:
        Aitken, Moira
        Phone: (206) 543-3166
        Email: moira@u.washington.edu
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