Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older
Phase 3
Active, not recruiting
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT05153317
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 71
Inclusion Criteria
key Inclusion Criteria:<br><br> - Completed study drug treatment in the parent study (VX20-445-111 Part B,<br> NCT04537793), or had study drug interruption(s) in the parent study, but did not<br> permanently discontinue study drug, and completed study visits up to the last<br> scheduled visit of the Treatment Period of the parent study<br><br>Key Exclusion Criteria:<br><br> - History of study drug intolerance in the parent study<br><br> - History of poor compliance with ELX/TEZ/IVA and/or procedures in the parent study<br><br>Other protocol defined Inclusion/Exclusion criteria may apply
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Secondary Outcome Measures
Name Time Method Absolute Change in Sweat Chloride (SwCl);Absolute Change in Lung Clearance Index (LCI) 2.5