Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age

  • End date
    Jun 16, 2030
  • participants needed
  • sponsor
    Vertex Pharmaceuticals Incorporated
Updated on 7 October 2022
Medical Information
Primary Contact
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota (1.6 mi away) Contact
+7 other location
cftr gene


The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Condition Cystic Fibrosis
Treatment VX-121/TEZ/D-IVA
Clinical Study IdentifierNCT05422222
SponsorVertex Pharmaceuticals Incorporated
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

Participants with stable CF and at least 1 TCR mutation (including F508del) in the CFTR gene

Exclusion Criteria

History of solid organ, hematological transplantation, or cancer
Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
Lung infection with organisms associated with a more rapid decline in pulmonary status
Other protocol defined Inclusion/Exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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