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

Launched by VERTEX PHARMACEUTICALS INCORPORATED · Apr 24, 2023

Keywords

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Gender

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Eligibility criteria

• Key Inclusion Criteria:
• Parts A and B:
• • • Participants who have completed study drug treatment in the parent study (VX21-121-105; NCT Number: NCT05422222)
• Part B:
• -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
• Key Exclusion Criteria:
• • 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
• • Other protocol defined Inclusion/Exclusion criteria may apply.