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Restore CFTR Protein Enrolling
Phase 3 study of VX-121/tezacaftor/deutivacaftor in children 2 to 5 with cystic fibrosis (Vertex VX21-121-105 Cohort A2)
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.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
2 Years to 5 Years -
Mutation(s):
See Other Primary Eligibility Criteria -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Eligible participants must have at least one CFTR mutation that is responsive to triple combination therapy. (Mutation eligibility can be checked here). Eligible participant must weigh above the 5th percentile by CDC growth charts.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
7 weeks -
Number of Study Visits:
7
Additional Information
-
Phase: ?more info
Phase Three -
Study Sponsor: ?more info
Vertex -
Study Drugs:
Study Sites
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Closed to Enrollment
Colorado
Children's Hospital Colorado, Aurora, CO 80045
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Closed to Enrollment
Georgia
Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30322
-
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
-
Enrolling
Massachusetts
Boston Children's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
-
Enrolling Soon
Minnesota
Children’s Hospitals and Clinics of Minnesota, Minneapolis, MN 55404
Contact
Elizabeth Franck Thompson
Phone: +1 (612) 813-6347
Email: elizabeth.franckthompson@childrensmn.org
-
Enrolling
Missouri
St. Louis Children's Hospital, 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
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
Contact
Primary RC & Participant Contact General Contact
Phone: +1
Email: RainbowCFResearch@UHhospitals.org
-
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
-
Closed to Enrollment
Vermont
Vermont Children's Hospital, Burlington, VT 05401
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
2 Years to 5 Years -
Mutation(s):
See Other Primary Eligibility Criteria -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Eligible participants must have at least one CFTR mutation that is responsive to triple combination therapy. (Mutation eligibility can be checked here). Eligible participant must weigh above the 5th percentile by CDC growth charts.
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