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An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients Aged 4 to 11 Years With Activated Phosphoinositide 3-Kinase Delta Syndrome Followed by an Open-label Long-term Extension
Conditions
Interventions
Leniolisib
Locations
7
United States
University of California Los Angeles
Los Angeles, California, United States
Stanford University
Standford, California, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
National Institutes of Health
Bethesda, Maryland, United States
Necker Hospital Paris
Paris, France
Kyoto University Hospital
Kyoto, Japan
Start Date
February 1, 2023
Primary Completion Date
October 31, 2025
Completion Date
December 30, 2025
Last Updated
October 28, 2025
Lead Sponsor
Pharming Technologies B.V.
Collaborators
Data Source & Attribution
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