Status:
COMPLETED
Guided Discontinuation Versus Maintenance Treatment of Sirolimus in Pediatric Patients With Kaposiform Hemangioendothelioma
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Kaposiform Hemangioendothelioma
Kasabach-Merritt Syndrome
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE4
Brief Summary
This randomized controlled trial aims to compare guided discontinuation with maintenance treatment of sirolimus in pediatric patients with KHE.
Detailed Description
Kaposiform Hemangioendothelioma (KHE) is a rare vascular tumor that occurs in infants and children. KHE is characterized by sheets of spindle cells with an infiltrative pattern in the dermis, subcutan...
Eligibility Criteria
Inclusion
- Participant diagnosed with KHE with or without KMP
- Participant age 0-12 years
- Participant with detailed medical records of the disease at the time of screening
- Participant with at least two years of remission of KHE and no previous toxicity or adverse events
- Participant with normal liver and kidney function
- Participant with signed and dated informed consent from the guardian(s)
Exclusion
- Participant with other hematological diseases
- Participant with other solid tumor
- Participant with general disease such as hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney dysfunction, and cardiopulmonary insufficiency.
- Participant with infectious diseases
- Unwilling participant
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04448873
Start Date
July 1 2020
End Date
July 1 2023
Last Update
September 26 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 210012