NCT05844449

Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older

Enrolling by Invitation
PHASE3Ages 1+InterventionalTreatment
Vertex Pharmaceuticals Incorporated
~174 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:VNZ/TEZ/D-IVA

At a glance

Recruiting sites
0 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
Measured over From Baseline up to Week 100
+1 more outcome measured
Cystic Fibrosis
37 sites across 23 states
Australia4
Ohio3
Germany3
California2
Missouri2
Canada2
France2
Sweden2

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Meets at least 1 of the following criteria:
Completed study drug treatment in Part A
Had study drug interruption(s) in Part A, but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the treatment period of Part A

Exclusion

Hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe hepatic impairment that might pose an additional risk in administering study drug
History of solid organ, hematological transplantation, or cancer
History of drug intolerance in the parent study
  • Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)From Baseline up to Week 100
  • Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)From Baseline up to Week 196