Clinical Trial

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

Recruiting Phase 2/3
View on ClinicalTrials.gov →
Summary
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 Kaposiform Hemangioendothelioma (KHE), Kasabach Merritt Phenomenon
Enrollment 76 participants
Start Date 2026-06-16
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-18