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Low- vs High-Dose Sirolimus With Prednisolone for KHE and KMP

StatusRecruiting
PhasePhase 2/3
SponsorYi Ji
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
Yi Ji
1 trial monitored
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This randomized clinical trial evaluates if low-dose sirolimus (target trough 4-8 ng/mL) combined with prednisolone is noninferior in efficacy but superior in safety compared to standard high-dose sirolimus (target trough 10-15 ng/mL) combined with prednisolone in pediatric patients with kaposiform hemangioendothelioma and Kasabach-Merritt phenomenon (KHE with KMP), with participants randomized 1:1 to receive the assigned regimen, undergo routine blood and imaging monitoring, and be evaluated for clinical response and adverse events.
Trial Details
NCT Number NCT07656909
Lead Sponsor Yi Ji
Conditions
(from sponsor)		 Kaposiform Hemangioendothelioma (KHE), Kasabach Merritt Phenomenon
Related terms Kaposiform Hemangioendothelioma, Kasabach-Merritt Syndrome
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov