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
1-11 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: Between 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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