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Active Not Recruiting
NCT05444257
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
Conditions: Cystic Fibrosis
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 822
Sponsor: Vertex Pharmaceuticals Incorporated
Location: University of Alabama at Birmingham Birmingham Alabama
Summary
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
Eligibility Criteria
Key Inclusion Criteria:
* Part A: Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period in the parent study
* Part B: Completed study drug treatment in Part A; or 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
Key Exclusion Criteria:
* History of drug intolerance in a parent study
* Pregnant or breast-feeding females at the time of enrollment in Part A
Other protocol defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT05444257). StuddyBuddy aggregates publicly available trial information.
