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Restore CFTR Protein Closed to Enrollment
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.
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 more information about the results of this study and where it was conducted, 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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Closed to Enrollment
Alabama
University of Alabama at Birmingham, Birmingham, AL 35233
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Closed to Enrollment
Arizona
Tucson Cystic Fibrosis Center, Tucson, AZ 85724
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Closed to Enrollment
Arkansas
Arkansas Children's Hospital, Little Rock, AR 72202
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Closed to Enrollment
California
Children's Hospital of Los Angeles, Los Angeles, CA 90027
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Closed to Enrollment
California
Kaiser Permanente Medical Care Program, Oakland, CA 94611
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Closed to Enrollment
California
Miller Children's and Women's Hospital Long Beach, Long Beach, CA 90806
-
Closed to Enrollment
California
University of California at Davis Medical Center, Sacramento, CA 95817
-
Closed to Enrollment
California
University of California, San Francisco, SF, CA 94143
-
Closed to Enrollment
Colorado
National Jewish Health, Denver, CO 80206
-
Closed to Enrollment
Colorado
Children's Hospital Colorado, Aurora, CO 80045
-
Closed to Enrollment
Florida
All Children's Hospital, St. Petersburg, FL 33701
-
Closed to Enrollment
Florida
The Nemours Children's Clinic - Orlando, Orlando, FL 32827
-
Closed to Enrollment
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
-
Closed to Enrollment
Florida
University of Florida, Gainesville, FL 32610
-
Closed to Enrollment
Florida
Joe DiMaggio Children's Hospital, Hollywood, FL 33021
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Closed to Enrollment
Georgia
Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30329
-
Closed to Enrollment
Georgia
Augusta University, Augusta, GA 30912
-
Closed to Enrollment
Idaho
Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702
-
Closed to Enrollment
Illinois
Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL 60611
-
Closed to Enrollment
Illinois
Northwestern University, Chicago, IL 60611
-
Closed to Enrollment
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
-
Closed to Enrollment
Indiana
Indiana University Medical Center, Indianapolis, IN 46202
-
Closed to Enrollment
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
-
Closed to Enrollment
Kentucky
University of Kentucky, Lexington, KY 40536
-
Closed to Enrollment
Kentucky
University of Louisville, Louisville, KY 40202
-
Closed to Enrollment
Louisiana
Tulane University, Metairie, LA 70006
-
Closed to Enrollment
Massachusetts
Massachusetts General Hospital, Boston, MA 02114
-
Closed to Enrollment
Massachusetts
University of Massachusetts Memorial Health Care, Worcester, MA 01655
-
Closed to Enrollment
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115
-
Closed to Enrollment
Michigan
University of Michigan, Michigan Medicine, Ann Arbor, MI 48109
-
Closed to Enrollment
Michigan
Corewell Health Helen DeVos, Grand Rapids , MI 49503
-
Closed to Enrollment
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455
-
Closed to Enrollment
Missouri
SSM Health Cardinal Glennon Children’s Hospital, St. Louis, MO 63104
-
Closed to Enrollment
Missouri
Washington University School of Medicine, St. Louis, MO 63110
-
Closed to Enrollment
Missouri
University of Missouri Health Sciences Center, Columbia, MO 65212
-
Closed to Enrollment
Missouri
Children's Mercy Kansas City, Kansas City, MO 64108
-
Closed to Enrollment
Montana
Billings Clinic , Billings, MT 59101
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Closed to Enrollment
Nebraska
University of Nebraska Medical Center, Omaha, NE 68198
-
Closed to Enrollment
New Hampshire
Dartmouth Hitchcock Medical Center, Lebanon, NH 03756
-
Closed to Enrollment
New Jersey
Morristown Medical Center , Morristown, NJ 07960
-
Closed to Enrollment
New York
Albany Medical College, Albany, NY 12208
-
Closed to Enrollment
New York
The Cystic Fibrosis Center of Western New York, Buffalo, NY 14203
-
Closed to Enrollment
New York
Long Island Jewish Medical Center, New Hyde Park, NY 11042
-
Closed to Enrollment
New York
Columbia University Cystic Fibrosis Program, New York, NY 10032
-
Closed to Enrollment
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
-
Closed to Enrollment
North Carolina
Atrium Health Wake Forest Baptist, Winston-Salem, NC 27157
-
Closed to Enrollment
Ohio
Dayton Children's Hospital, Dayton, OH 45404
-
Closed to Enrollment
Ohio
Toledo Children's Hospital, Toledo, OH 43606
-
Closed to Enrollment
Ohio
Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195
-
Closed to Enrollment
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
-
Closed to Enrollment
Oregon
Oregon Health & Science University, Portland, OR 97239
-
Closed to Enrollment
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, PA 19104
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Closed to Enrollment
Pennsylvania
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224
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Closed to Enrollment
South Dakota
Sanford USD Medical Center, Sioux Falls, SD 57117
-
Closed to Enrollment
Tennessee
Vanderbilt University Medical Center, Nashville, TN 37232
-
Closed to Enrollment
Texas
Driscoll Children's Hospital, Corpus Christi, TX 78411
-
Closed to Enrollment
Texas
Cook Children's Medical Center, Fort Worth, TX 76104
-
Closed to Enrollment
Texas
University of Texas Southwestern, Dallas, TX 75390
-
Closed to Enrollment
Texas
Baylor College of Medicine, Houston, TX 77030
-
Closed to Enrollment
Utah
Adult Cystic Fibrosis Center at the University of Utah, Salt Lake City, UT 84112
-
Closed to Enrollment
Vermont
University of Vermont Medical Center, Burlington, VT 05401
-
Closed to Enrollment
Virginia
University of Virginia, Charlottesville, VA 22903
-
Closed to Enrollment
Virginia
Inova Fairfax, Falls Church, VA 22042
-
Closed to Enrollment
Washington
University of Washington Medical Center, Seattle, WA 98195
-
Closed to Enrollment
Wisconsin
University of Wisconsin, Madison, WI 53792
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 more information about the results of this study and where it was conducted, 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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