Active, not yet recruiting
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis
NCT No.: NCT05444257
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: California - Northern
Acronym:
Official Title
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis
Purpose
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.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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• 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
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Exclusion Criteria
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• 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.
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Keywords and/or Specific Medical Conditions
- Digestive System Diseases
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- Respiratory Tract Diseases
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Sponsors
- Vertex Pharmaceuticals Incorporated
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