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Completed
NCT05882357
Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age
Conditions: Cystic Fibrosis
Sex: All
Ages: 12 Months – 24 Months
Healthy volunteers: No
Phase: PHASE3
Enrollment: 67
Sponsor: Vertex Pharmaceuticals Incorporated
Location: Telethon Kids Institute Nedlands
Summary
The study evaluates the pharmacokinetics (PK), safety, tolerability, pharmacodynamics (PD), and efficacy of ELX/TEZ/IVA in CF participants 2 to less than (\
Eligibility Criteria
Key Inclusion Criteria:
Participants who have at least 1 F508del mutation in the CF transmembrane conductance regulator (CFTR) gene or another ELX/TEZ/IVA-responsive CFTR mutation
Key Exclusion Criteria:
History of any illness or any clinical condition that, in the opinion of the investigator, might either confound the results of the study or pose an additional risk in administering study drug(s) to the participant
Other protocol defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT05882357). StuddyBuddy aggregates publicly available trial information.
