Page Title
Clinical Trial Finder
Restore CFTR Function Enrolling
Study of VX-121 in people with CF ages 12 years and older who have one copy of the F508del mutation and one copy of a minimal function mutation (Vertex VX20-121-102)
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 in combination with 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):
One Copy F508del -
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 one copy of F508del and one copy of a minimal function CFTR mutation. Click here to see a list of eligible minimal function 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
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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
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Enrolling Soon
California
Kaiser Permanente Medical Care Program, Oakland, CA 94611
Contact
Phone: +1
Email:
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Enrolling Soon
California
Miller Children's and Women's Hospital Long Beach, Long Beach, CA 90806
Contact
Marylee Melendrez
Phone: +1 (562) 933-1851
Email: mmelendrez@memorialcare.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
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Enrolling Soon
California
University of California, San Francisco, SF, CA 94143
Contact
Courtney Moreno
Phone: +1 (415) 476-2984
Email: Courtney.Moreno@ucsf.edu
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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
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 Soon
Florida
The Nemours Children's Clinic - Orlando, Orlando, FL 32827
Contact
Sherry Wooldridge
Phone: +1 (407) 650-7273
Email: sherry.wooldridge@nemours.org
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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 Florida, Gainesville, FL 32610
Contact
Alexa Smith
Phone: +1
Email: alexa.howell@ufl.edu
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Enrolling
Florida
Joe DiMaggio Children's Hospital, Hollywood, FL 33021
Contact
Doris Alaby
Phone: +1 (954) 265-1863
Email: dalaby@mhs.net
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Enrolling
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
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Enrolling Soon
Georgia
Augusta University, Augusta, GA 30912
Contact
Heidi Stapp
Phone: +1 (706) 721-7699
Email: hstapp@augusta.edu
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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
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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
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
Contact
Lawrence Scott
Phone: +1 (913) 588-4020
Email: lscott2@kumc.edu
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Enrolling Soon
Kentucky
University of Louisville, Louisville, KY 40202
Contact
Melissa Thomas
Phone: +1
Email: mcthom12@louisville.edu
-
Enrolling
Louisiana
Tulane University, New Orleans, LA 70112
Contact
Carol Rockwell
Phone: +1 (504) 988-2325
Email: crockwell@tulane.edu
-
Enrolling
Louisiana
Tulane University, Metairie, LA 70001
Contact
Nicole Falgout
Phone: +1 (504) 988-2566
Email: nfalgout@tulane.edu
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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 49503
Contact
Heather Mulroy
Phone: +1 (616) 391-0384
Email: heather.mulroy@spectrumhealth.org
-
Enrolling
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455
Contact
Participant Contact University of Minnesota
Phone: +1
Email: cftrials@umn.edu
-
Enrolling
Missouri
SSM Health Cardinal Glennon Children’s Hospital, St. Louis, MO 63104
Contact
Freda Branch
Phone: +1 (314) 678-5468
Email: freda.branch@health.slu.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
Montana
Billings Clinic , Billings, MT 59101
Contact
Jerimiah Lysinger
Phone: +1 (406) 238-5137
Email: JLysinger@billingsclinic.org
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Enrolling Soon
Nebraska
University of Nebraska Medical Center, Omaha, NE 68198
Contact
James Melson
Phone: +1 (402) 559-9101
Email: jmelson@unmc.edu
-
Enrolling
New Hampshire
Dartmouth Hitchcock Medical Center, Lebanon, NH 03756
Contact
Barbara Rodgers
Phone: +1 (603) 650-9718
Email: Barbara.A.Rodgers@hitchcock.org
-
Enrolling
New Jersey
Morristown Medical Center , Morristown, NJ 07960
Contact
Nancy Martinez
Phone: +1 (973) 971-5138
Email: nancy.martinez@atlantichealth.org
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Enrolling
New York
Albany Medical College, Albany, NY 12208
Contact
Terese Evans
Phone: +1 (518) 262-5293
Email: evansmt@mail.amc.edu
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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
-
Enrolling
New York
Long Island Jewish Medical Center, New Hyde Park, NY 11042
Contact
Phone: +1
Email:
-
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
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Enrolling
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
Contact
Zachary Messer
Phone: +1 (914) 594-2352
Email: Zachary_Messer@nymc.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
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Enrolling
Ohio
Dayton Children's Hospital, Dayton, OH 45404
Contact
Sandy Bartosik
Phone: +1 (937) 641-4004
Email: bartosiks@childrensdayton.org
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Enrolling Soon
Ohio
Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195
Contact
Dave Weaver
Phone: +1 (216) 445-6671
Email: weaverd@ccf.org
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Enrolling
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
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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
South Dakota
Sanford USD Medical Center, Sioux Falls, SD 57117
Contact
Sara Onnen
Phone: +1 (605) 328-1374
Email: Sara.Onnen@SanfordHealth.org
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Enrolling Soon
Tennessee
Vanderbilt University Medical Center, Nashville, TN 37232
Contact
Brijesh Patel
Phone: +1 (615) 343-4865
Email: brijesh.patel@vumc.org
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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
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Enrolling Soon
Texas
Baylor College of Medicine, Houston, TX 77030
Contact
Katie Howe
Phone: +1 (832) 822-4252
Email: klhowe@texaschildrens.org
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Enrolling
Utah
Intermountain Cystic Fibrosis Center, University of Utah, Salt Lake City, UT 84132
Contact
Kristyn Packer
Phone: +1 (801) 585-0401
Email: kristyn.packer@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 Soon
Washington
University of Washington Medical Center, Seattle, WA 98195
Contact
Teresa Gambol
Phone: +1 (206) 543-7382
Email: TGambol@medicine.washington.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):
One Copy F508del -
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 one copy of F508del and one copy of a minimal function CFTR mutation. Click here to see a list of eligible minimal function mutations.
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