Page Title
Clinical Trial Finder
Restore CFTR Protein Closed to Enrollment
Phase 3 study of VX-121/tezacaftor/deutivacaftor in?children ages 6 to 11 with cystic fibrosis (Vertex VX21-121-105 Cohort B1)
This study is taking place at multiple care centers across the U.S. It will look at safety and tolerability and how the body processes the drug VX-121/tezacaftor/deutivacaftor in participants with at least one triple-combination responsive CF mutation.
All study participants will receive the study drug, which means that no placebo will be used in this study. Researchers will test safety by monitoring the frequency of adverse events. They will monitor how the body processes the drug VX-121/tezacaftor/deutivacaftor by monitoring the concentration of the drug in the blood.??
This study may require blood draws and/or other measurements.??
Eligibility
See other primary eligibility criteria for more information.
-
Age:
6 Years to 11 Years -
Mutation(s):
See Other Primary Eligibility Criteria -
FEV1% Predicted:
60% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Eligible participants must have at least one triple combination responsive CFTR mutation. Eligible participants weight (without shoes) must be between the 5th and 95th percentile weight-for-age at the Screening Visit based on current CDC growth charts.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
32 weeks -
Number of Study Visits:
8
Additional Information
-
Phase: ?more info
Phase Three -
Study Sponsor: ?more info
Vertex -
Study Drugs:
Study Sites
-
Closed to Enrollment
California
CHOC Children's Hospital, Orange, CA 92868
-
Closed to Enrollment
California
Stanford University Medical Center, Palo Alto, CA 94304
-
Closed to Enrollment
Colorado
Children's Hospital Colorado, Aurora, CO 80045
-
Closed to Enrollment
Georgia
Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30329
-
Closed to Enrollment
Illinois
Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL 60611
-
Closed to Enrollment
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
-
Closed to Enrollment
Massachusetts
Boston Children's Hospital, Boston, MA 02115
-
Closed to Enrollment
Minnesota
Children’s Hospitals and Clinics of Minnesota, Minneapolis, MN 55404
-
Closed to Enrollment
Missouri
St. Louis Children's Hospital, St. Louis, MO 63110
-
Closed to Enrollment
Missouri
Children's Mercy Kansas City, Kansas City, MO 64108
-
Closed to Enrollment
New York
Cohen Children's Medical Center of New York, New Hyde Park, NY 11042
-
Closed to Enrollment
Ohio
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229
-
Closed to Enrollment
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
-
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 Pittsburgh of UPMC, Pittsburgh, PA 15224
-
Closed to Enrollment
Texas
Baylor College of Medicine, Houston, TX 77030
-
Closed to Enrollment
Vermont
Vermont Children's Hospital, Burlington, VT 05401
-
Closed to Enrollment
Wisconsin
University of Wisconsin, Madison, WI 53792
Eligibility
See other primary eligibility criteria for more information.
-
Age:
6 Years to 11 Years -
Mutation(s):
See Other Primary Eligibility Criteria -
FEV1% Predicted:
60% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Eligible participants must have at least one triple combination responsive CFTR mutation. Eligible participants weight (without shoes) must be between the 5th and 95th percentile weight-for-age at the Screening Visit based on current CDC growth charts.

CONTACT THE CLINICAL TRIAL NAVIGATOR
Get personalized assistance and answers to your clinical trial questions.
Learn MoreSign up for clinical trial alerts
Get email updates about clinical trials that matter to you.
Check the Drug Development Pipeline
We’re attacking CF from every angle. Learn about the status of CF drugs in development.
Learn More