NCT05422222
Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
Active, Not Recruiting
PHASE3Ages 1–11InterventionalTreatmentVertex Pharmaceuticals Incorporated
~210 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:VX-121/TEZ/D-IVA
At a glance
Recruiting sites
0 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Observed Pre-dose Plasma Concentration (Ctrough) of VX-121, TEZ, D-IVA, and Relevant Metabolites
Measured over From Day 1 up to Day 22
+2 more outcomes measured
Conditions
Where it's being run
38 sites across 24 statesAustralia4
Ohio3
Germany3
California2
Missouri2
Canada2
France2
Sweden2
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants with stable CF and at least 1 TCR mutation (including F508del) in the CFTR gene
Exclusion
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
What this trial measures
- Part A: Observed Pre-dose Plasma Concentration (Ctrough) of VX-121, TEZ, D-IVA, and Relevant MetabolitesFrom Day 1 up to Day 22
- Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From Day 1 up to Day 50
- Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From Day 1 up to Week 28