|
|
| Study Name: |
VX-661 alone and in combination with Kalydeco in People with Cystic Fibrosis and F508del-CFTR mutation |
| Study Type: |
Interventional |
| Intervention Category: |
CFTR Modulation |
| Study Sponsor: |
Vertex |
| Study Phase: |
2 |
| Recruitment Status: |
Recruiting |
| 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 Kalydeco 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. |
| 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. |
| Sponsor Contact Information: |
Medical Monitor, Vertex
(617) 444-6777
medicalinfo@vrtx.com
|
| 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 and Adult), 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:
Symington, Thomas
Phone: (616) 391-9366
Email: thomas.symington@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@sbhcs.com
|
| 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:
Duan, Lorrie
Phone: (513) 636-7089
Email: lorrie.duan@cchmc.org
-
Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
Contact Information:
Johnson, Mary Terri
Phone: (614) 722-4766
Email: Terri.Johnson@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:
Diehl, Sandra
Phone: (802) 847-3884
Email: Sandra.Diehl@uvm.edu
|
| WA |
-
University of Washington Medical Center (Adult), Seattle, WA, 98195
Contact Information:
Wolfstone, Alycia
Phone: (206) 685-3995
Email: aewolf@u.washington.edu
|
|
