Search

Page Title

Clinical Trial Finder

Back to the Clinical Trial Finder

Restore CFTR Protein Closed to Enrollment

Study of VX-828 in combination with Tezacaftor and Deutivacaftor in healthy participants and in adults with cystic fibrosis. (Vertex VX23-828-001 Phase 1 Part E)

Part E of this study will look at the safety and tolerability of VX-828 in combination with Tezacaftor and Deutivacaftor in adults with CF. The drug combination is intended to help CFTR function closer to normal.

 

Part E is open label, which means all study participants will receive the study drug. Researchers will assess the safety and tolerability of VX-828 by monitoring lung function tests, lab tests, and changes in health.

 

This study may require measuring lung function, blood draws, and sweat tests.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    One Copy F508del

  • FEV1% Predicted:

    40% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Participants will have one copy of F508del and one copy of a minimal function mutation that is not responsive to ELX/TEZ/IVA therapy. A 28-day Trikafta run-in period will be waived for participants who are on stable Trikafta treatment.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    4 months

  • Number of Study Visits:

    12

Additional Information

  • Phase: ?more info

    Phase One

  • Study Sponsor: ?more info

    Vertex

  • Study Drugs:

    VX-828

Study Sites

  • Closed to Enrollment

    Florida

    Central Florida Pulmonary Group, Orlando, FL 32803

  • Closed to Enrollment

    Kentucky

    University of Kentucky, Lexington, KY 40536

  • Closed to Enrollment

    Massachusetts

    Boston Children's Hospital, Boston, MA 02115

  • Closed to Enrollment

    Minnesota

    The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455

  • Closed to Enrollment

    New York

    New York Medical College at Westchester Medical Center, Valhalla, NY 10595

  • Closed to Enrollment

    Ohio

    Toledo Children's Hospital, Toledo, OH 43606

  • Closed to Enrollment

    Texas

    Cook Children's Medical Center, Fort Worth, TX 76104

  • 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

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    One Copy F508del

  • FEV1% Predicted:

    40% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Participants will have one copy of F508del and one copy of a minimal function mutation that is not responsive to ELX/TEZ/IVA therapy. A 28-day Trikafta run-in period will be waived for participants who are on stable Trikafta treatment.

CONTACT THE CLINICAL TRIAL NAVIGATOR

Get personalized assistance and answers to your clinical trial questions.

Learn More

Sign 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