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

J
James Chmiel

Primary Investigator

Enrolling By Invitation
1 year - 11 years
All
Phase 3
210 participants needed
1 Location

Brief description of study

The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability andy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembraneductance regulator (CFTR) gene.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cystic Fibrosis, Riley
  • Age: 1 year - 11 years
  • Gender: All

Key Inclusion Criteria:
  • Participants with stable CF and at least 1 TCR mutation (including F508del) in theCFTR gene
Key Exclusion Criteria:
  • History of solid organ, hematological transplantation, or cancer
  • Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh7 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.

Updated on 12 Sep 2024. Study ID: VX21-121-105, PPUL-VERTEX-VX21-121-105, 16416
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only