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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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06460506). StuddyBuddy aggregates publicly available trial information.