Page Title
Clinical Trial Finder
Restore CFTR Protein Enrolling
Phase 3 study of VX-121/tezacaftor/deutivacaftor in children ages 2 to 5 with cystic fibrosis (Vertex VX21-121-105 Cohort B2 )
This study is taking place at multiple care centers across the U.S. It will look at the 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).
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
-
Enrolling Soon
California
CHOC Children's Hospital, Orange, CA 92868
Contact
Lila Klein
Phone: +1 (714) 509-4341
Email: Lila.klein@choc.org
-
Enrolling Soon
California
Stanford University Medical Center, Palo Alto, CA 94304
Contact
Jacquelyn Spano
Phone: +1 (650) 721-1132
Email: jmzirbes@stanford.edu
-
Enrolling Soon
Colorado
Children's Hospital Colorado, Aurora, CO 80045
Contact
Mary Cross
Phone: +1 (720) 777-4645
Email: mary.cross@childrenscolorado.org
-
Enrolling Soon
Georgia
Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30329
Contact
Ashleigh Streby
Phone: +1 (404) 727-0305
Email: ashleigh.streby@emory.edu
-
Enrolling Soon
Illinois
Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL 60611
Contact
Tina Carter
Phone: +1
Email: tmcarter@luriechildrens.org
-
Enrolling Soon
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
-
Enrolling Soon
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 Soon
Missouri
St. Louis Children's Hospital, St. Louis, MO 63110
Contact
Irma Bauer
Phone: +1 (314) 747-2940
Email: irmabauer@wustl.edu
-
Enrolling Soon
Missouri
Children's Mercy Kansas City, Kansas City, MO 64108
Contact
Jana Lomonte
Phone: +1 (816) 302-6308
Email: jblomonte@cmh.edu
-
Enrolling Soon
Ohio
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229
Contact
Kelly Thornton
Phone: +1 (513) 636-0604
Email: Kelly.Thornton@cchmc.org
-
Enrolling Soon
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
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.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
-
Enrolling Soon
Texas
Baylor College of Medicine, Houston, TX 77030
Contact
Tracy Mosely
Phone: +1 (832) 822-3309
Email: tlmosely@texaschildrens.org
-
Enrolling Soon
Vermont
Vermont Children's Hospital, Burlington, VT 05401
Contact
Julie Sweet
Phone: +1 (802) 847-7958
Email: julie.sweet@uvmhealth.org
-
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:
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).

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