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Active Not Recruiting
NCT06460506
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
Conditions: Cystic Fibrosis
Sex: All
Ages: 12 Months – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 50
Sponsor: Vertex Pharmaceuticals Incorporated
Location: The Kids Research Institute Australia Nedlands
Summary
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
Eligibility Criteria
Key Inclusion Criteria:
* Completed study drug treatment in the parent study VX22-445-122 Part B (NCT05882357) OR had study drug interruption(s) in the parent study but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the Treatment Period of the parent study
Key Exclusion Criteria:
* History of drug intolerance in the parent study that would pose an additional risk to the participant
* Current participation in an investigational drug trial other than the parent study
Other protocol defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT06460506). StuddyBuddy aggregates publicly available trial information.