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Clinical trial

Safety and Efficacy of Low-dose Sirolimus to Kaposiform Hemangioendothelioma:A Prospective, Randomized Open Trial

ID
Name
2019-161
Description
to evaluate the safety and efficacy of Low-dose sirolimus in Kaposiform Hemangioendothelioma in Chinese children by a prospective, randomized open trial.
Trial arms
Trial start
2019-05-01
Estimated PCD
2022-12-10
Trial end
2022-12-31
Status
Completed
Phase
Early phase I
Treatment
Sirolimus(0.8mg/m2)
The initial use of sirolimus is 0.8mg/m2 administered twice daily.After two weeks of taking the drug, blood concentrations are measured and adjusted appropriately to maintain the targeted blood concentration.
Arms:
high blood concentration group
Other names:
Rapamycin
Sirolimus(0.7mg/m2)
The initial use of sirolimus is 0.7mg/m2 administered twice daily.After two weeks of taking the drug, blood concentrations are measured and adjusted appropriately to maintain the targeted blood concentration.
Arms:
low blood concentration group
Other names:
Rapamycin
Size
92
Primary endpoint
response to treatment
1 year after taking the drug
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 92, 'type': 'ACTUAL'}}
Updated at
2023-01-30

1 organization

2 products

2 indications

Organization
Children's Hospital of Fudan University
Product
Sirolimus(0.8mg/m2)
Indication
Hemangioma
Indication
Kaposiform Hemangioendothelioma
Product
Sirolimus(0.7mg/m2)