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Restore CFTR Protein Closed to Enrollment

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.

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 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 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

Study Sites

  • 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

    Ohio

    Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106

  • Closed to Enrollment

    Pennsylvania

    Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224

  • Closed to Enrollment

    Vermont

    Vermont Children's Hospital, Burlington, VT 05401

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 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 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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