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Clinical trial

A Two-stage Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

NCT05948943 is registered in ClinicalTrials.gov with Novartis Pharmaceuticals as lead sponsor.

NCT NCT05948943
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Registry record

As filed in ClinicalTrials.gov.

Title
A Two-stage Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
Lead sponsor
Novartis Pharmaceuticals
Phase
Phase 2/3
Overall status
Recruiting
Start date
November 24, 2023
Completion date
May 2, 2033
Enrollment
232 (estimated)
Sites
61

Conditions

As the registry lists them; a condition with its own page is linked.

lymphatic malformations