Page Title
Clinical Trial Finder
Restore CFTR Function Enrolling
Study of VX-121 in people with CF ages 12 years and older who have either two copies of the F508del mutation, one copy of the F508del mutation and one copy of a gating or residual function mutation, or no copies of the F508del mutation and at least one other triple combination responsive CFTR mutation (Vertex VX20-121-103)
This study will look at the safety and effectiveness of VX-121/tezacaftor/deutivacaftor, a drug combination intended to help CFTR protein function closer to normal.
This study will test once-a-day dosing by using an active comparator. This means that some participants will receive the study drug or a placebo in the morning, and others will receive Trikafta®(elexacaftor/tezacaftor/ivacaftor) or a placebo in the morning and ivacaftor or a placebo in the evening. Researchers will test the effectiveness of the VX-121/tezacaftor/deutivacaftor combination by measuring changes in lung function and sweat chloride.
This study may require lung function tests, sweat tests, blood draws, and/or other measures.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
See Other Primary Eligibility Criteria -
FEV1% Predicted:
40 to 90%
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Study participants must have either two copies of the F508del mutation, one copy of the F508del mutation and one copy of a gating or residual function mutation, or no copies of the F508del mutation and at least one other triple combination responsive CFTR mutation. Click here to see a list of eligible mutations.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
64 weeks -
Number of Study Visits:
10
Additional Information
-
Phase: ?more info
Phase Three -
Study Sponsor: ?more info
Vertex -
Study Drugs:
Study Sites
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Enrolling Soon
Alabama
University of Alabama at Birmingham, Birmingham, AL 35294
Contact
Heather Hathorne
Phone: +1 (205) 638-9568
Email: hyhathorne@uabmc.edu
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Enrolling Soon
Arizona
Tucson Cystic Fibrosis Center, Tucson, AZ 85724
Contact
Elizabeth Ryan
Phone: +1 (520) 850-8688
Email: elizabethryan@email.arizona.edu
-
Enrolling
Arkansas
University of Arkansas for Medical Sciences, Little Rock, AR 72205
Contact
Kathleen Hicks
Phone: +1 (501) 686-5527
Email: HicksKathleenT@uams.edu
-
Enrolling
California
Children's Hospital of Los Angeles, Los Angeles, CA 90027
Contact
Carmen Reyes
Phone: +1 (323) 361-2662
Email: mareyes@chla.usc.edu
-
Enrolling
California
CHOC Children's Hospital, Orange, CA 92868
Contact
Julie Nguyen Ballo
Phone: +1 (714) 509-3632
Email: Julie.Nguyen@choc.org
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Enrolling Soon
California
University of California at Davis Medical Center, Sacramento, CA 95817
Contact
Brandt Robinson
Phone: +1 (916) 734-8686
Email: brrobinson@ucdavis.edu
-
Enrolling Soon
Colorado
National Jewish Health, Denver, CO 80206
Contact
Alix Wilson
Phone: +1 (303) 270-2517
Email: wilsona@njhealth.org
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Enrolling Soon
Colorado
Children's Hospital Colorado, Aurora, CO 80045
Contact
Mary Cross
Phone: +1 (720) 777-4645
Email: mary.cross@childrenscolorado.org
-
Enrolling
Connecticut
Yale University School of Medicine, New Haven, CT 06520
Contact
Jonathan Koff
Phone: +1 (203) 737-6963
Email: jon.koff@yale.edu
-
Enrolling
Florida
All Children's Hospital, St. Petersburg, FL 33701
Contact
Diana Hodge
Phone: +1 (727) 767-6881
Email: dhodge6@jhmi.edu
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Enrolling
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
Contact
Kathleen Summo
Phone: +1 (407) 841-1100
Email: ksummo@cfpulmonary.com
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Enrolling
Florida
University of Miami, Miami, FL 33136
Contact
Ivan Whitaker
Phone: +1 (305) 243-5545
Email: pgraham1@med.miami.edu
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Enrolling Soon
Florida
Nemours Children's Health - Pensacola, Pensacola, FL 32514
Contact
Rebecca Davis
Phone: +1 (850) 473-4553
Email: Rebecca.Davis@nemours.org
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Enrolling Soon
Florida
Nemours Children's Clinic, Jacksonville, FL 32207
Contact
Jennifer (Jenn) Gafford
Phone: +1 (904) 697-3600
Email: Jennifer.gafford@nemours.org
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Enrolling Soon
Georgia
Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30322
Contact
Ashleigh Streby
Phone: +1 (404) 727-0305
Email: ashleigh.streby@emory.edu
-
Enrolling
Idaho
Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702
Contact
Dixie Durham
Phone: +1 (208) 381-7334
Email: durhamd@slhs.org
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Enrolling Soon
Illinois
Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL 60611
Contact
Larissa Rugg
Phone: +1 (312) 227-6865
Email: lrugg@luriechildrens.org
-
Enrolling
Illinois
Northwestern University, Chicago, IL 60611
Contact
Rachel Nelson
Phone: +1 (312) 695-0415
Email: rachel.nelson@northwestern.edu
-
Enrolling
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
-
Enrolling
Indiana
Indiana University Medical Center, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
-
Enrolling
Kentucky
University of Kentucky, Lexington, KY 40506
Contact
Christina Payne
Phone: +1 (859) 257-5087
Email: Christina.Payne@uky.edu
-
Enrolling
Louisiana
Tulane University, New Orleans, LA 70112
Contact
Carol Rockwell
Phone: +1 (504) 988-2325
Email: crockwell@tulane.edu
-
Closed to Enrollment
Louisiana
Tulane University, Metairie, LA 70001
-
Enrolling
Maine
Maine Medical Partners Pediatric Specialty Care, Portland, ME 04102
Contact
Rebecca Edwards
Phone: +1 (207) 662-6712
Email: REdwards1@mmc.org
-
Enrolling Soon
Massachusetts
Massachusetts General Hospital, Boston, MA 02114
Contact
Margot Hardcastle
Phone: +1 (617) 726-3719
Email: mhardcastle@mgh.harvard.edu
-
Enrolling
Massachusetts
University of Massachusetts Memorial Health Care, Worcester, MA 01655
Contact
Jaclyn Longtine
Phone: +1 (508) 856-5472
Email: Jaclyn.Longtine@umassmed.edu
-
Enrolling
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
-
Enrolling
Michigan
University of Michigan, Michigan Medicine, Ann Arbor, MI 48109
Contact
Dawn Kruse
Phone: +1 (734) 615-3266
Email: dmkruse@med.umich.edu
-
Enrolling
Michigan
Helen DeVos Children's Hospital, Grand Rapids, MI 49546
Contact
Heather Mulroy
Phone: +1 (616) 391-0384
Email: heather.mulroy@spectrumhealth.org
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Enrolling Soon
Michigan
Wayne State University Harper University Hospital, Detroit, MI 48201
Contact
Debra Driscoll
Phone: +1 (313) 745-2221
Email: ddriscol@med.wayne.edu
-
Enrolling
Missouri
Washington University School of Medicine, St. Louis, MO 63110
Contact
Irma Bauer
Phone: +1 (314) 747-2940
Email: irmabauer@wustl.edu
-
Enrolling
Missouri
Children's Mercy Kansas City, Kansas City, MO 64108
Contact
Candy Schmoll
Phone: +1 (816) 302-3538
Email: cschmoll@cmh.edu
-
Enrolling Soon
Montana
Billings Clinic , Billings, MT 59101
Contact
Jerimiah Lysinger
Phone: +1 (406) 238-5137
Email: JLysinger@billingsclinic.org
-
Enrolling
New Jersey
Morristown Medical Center , Morristown, NJ 07960
Contact
Nancy Martinez
Phone: +1 (973) 971-5138
Email: nancy.martinez@atlantichealth.org
-
Enrolling
New York
The Cystic Fibrosis Center of Western New York, Buffalo, NY 14203
Contact
Christine Roach
Phone: +1 (716) 323-0072
Email: croach@upa.chob.edu
-
Closed to Enrollment
New York
Long Island Jewish Medical Center, New Hyde Park, NY 11042
-
Enrolling
New York
Columbia University Cystic Fibrosis Program, New York, NY 10032
Contact
Emily DiMango
Phone: +1 (212) 305-0290
Email: ead3@cumc.columbia.edu
-
Enrolling
New York
SUNY Upstate Medical University, Syracuse, NY 13210
Contact
Mary Forell
Phone: +1 (315) 464-9209
Email: forellm@upstate.edu
-
Enrolling
North Carolina
Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157
Contact
Kay Powell
Phone: +1 (336) 713-8559
Email: kapowell@wakehealth.edu
-
Enrolling
Ohio
Dayton Children's Hospital, Dayton, OH 45404
Contact
Sandy Bartosik
Phone: +1 (937) 641-4004
Email: bartosiks@childrensdayton.org
-
Enrolling
Ohio
Toledo Children's Hospital, Toledo, OH 43606
Contact
Kelly Hoot
Phone: +1 (419) 291-4630
Email: kelly.hoot@promedica.org
-
Enrolling
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
-
Enrolling
Oklahoma
Oklahoma Cystic Fibrosis Center, OKC, OK 73104
Contact
Participant Contact Oklahoma Cystic Fibrosis Center
Phone: +1 (405) 271-6216
Email: cfresearchteam@ouhsc.edu
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Enrolling Soon
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, PA 19104
Contact
Erin Donnelly
Phone: +1 (267) 426-9626
Email: Donnellye4@email.chop.edu
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Enrolling Soon
Pennsylvania
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224
Contact
Elizabeth Hartigan
Phone: +1 (412) 692-7060
Email: elizabeth.hartigan@chp.edu
-
Enrolling Soon
South Carolina
University of South Carolina School of Medicine, Columbia, SC 29203
Contact
Judith Neff
Phone: +1 (803) 434-4986
Email: Judith.neff@prismahealth.org
-
Enrolling Soon
South Dakota
Sanford USD Medical Center, Sioux Falls, SD 57117
Contact
Sara Onnen
Phone: +1 (605) 328-1374
Email: Sara.Onnen@SanfordHealth.org
-
Enrolling Soon
Tennessee
Vanderbilt University Medical Center, Nashville, TN 37232
Contact
Brijesh Patel
Phone: +1 (615) 343-4865
Email: brijesh.patel@vumc.org
-
Enrolling
Texas
Cook Children's Medical Center, Fort Worth, TX 76104
Contact
Heather Urbanek
Phone: +1 (682) 885-1244
Email: Heather.Urbanek@cookchildrens.org
-
Enrolling
Texas
University of Texas Southwestern, Dallas, TX 75390
Contact
Ashley Keller
Phone: +1 (214) 648-6233
Email: Ashley.Keller@UTSouthwestern.edu
-
Enrolling
Utah
Primary Children's Cystic Fibrosis Center, Salt Lake City, UT 84113
Contact
Jane Vroom
Phone: +1 (801) 587-7458
Email: jane.vroom@hsc.utah.edu
-
Enrolling
Vermont
University of Vermont Medical Center, Burlington, VT 05401
Contact
Julie Sweet
Phone: +1 (802) 847-7958
Email: julie.sweet@uvmhealth.org
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Enrolling Soon
Virginia
University of Virginia, Charlottesville, VA 22903
Contact
Erica Tharrington
Phone: +1 (434) 297-7773
Email: SFV6AB@hscmail.mcc.virginia.edu
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Enrolling
Washington
Providence Medical Group, Cystic Fibrosis Clinic – Pediatrics, Spokane, WA 99204
Contact
Joan Milton
Phone: +1 (509) 474-4323
Email: joan.milton@providence.org
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Enrolling Soon
Washington
University of Washington Medical Center, Seattle, WA 98195
Contact
Teresa Gambol
Phone: +1 (206) 543-7382
Email: TGambol@medicine.washington.edu
-
Enrolling
West Virginia
West Virginia University - Morgantown, Morgantown, WV 26507
Contact
Tammy Clark
Phone: +1 (304) 293-5264
Email: tclark@hsc.wvu.edu
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Enrolling Soon
Wisconsin
University of Wisconsin, Madison, WI 53792
Contact
Melanie Nelson
Phone: +1 (608) 265-4617
Email: mnelson@pediatrics.wisc.edu
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
See Other Primary Eligibility Criteria -
FEV1% Predicted:
40 to 90%
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Study participants must have either two copies of the F508del mutation, one copy of the F508del mutation and one copy of a gating or residual function mutation, or no copies of the F508del mutation and at least one other triple combination responsive CFTR mutation. Click here to see a list of eligible mutations.
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