Status:
COMPLETED
Safety and Efficacy of Low-dose Sirolimus to Kaposiform Hemangioendothelioma
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Hemangioma
Kaposiform Hemangioendothelioma
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE4
Brief Summary
to evaluate the safety and efficacy of Low-dose sirolimus in Kaposiform Hemangioendothelioma in Chinese children by a prospective, randomized open trial.
Detailed Description
The clinically commonly used dose of sirolimus for Kaposiform Hemangioendothelioma is 0.8 mg/m2 administered twice daily, and the blood concentration can be maintained at 10-15 ng/ml according to the ...
Eligibility Criteria
Inclusion
- Kaposiform Hemangioendotheliomas with or without Kasabach-Merritt Phenomenon.
- 0 - 12 years of age at the time of study entry.
- Male or female.
- Consent of parents (or the person having parental authority in families): Signed and dated written informed consent.
Exclusion
- with hematological diseases.
- with other solid tumors.
- with hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney dysfunction, and cardiopulmonary insufficiency.
- with tuberculosis,cytomegalovirus and Epstein-Barr virus infection before the treatment.
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04077515
Start Date
May 1 2019
End Date
December 31 2022
Last Update
January 30 2023
Active Locations (1)
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1
Children's Hospital of Fudan University
Shanghai, China, 210012