Status:
RECRUITING
The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Kaposiform Hemangioendothelioma
Eligibility:
All Genders
Up to 12 years
Brief Summary
To research and explore the antibody protection and immune memory after vaccination in children with KHE during sirolimus administration. To explore the feasibility (safety and efficacy) of vaccinatio...
Detailed Description
Children with KHE have an early onset. KHE usually occurs in infants and young children less than 1 year old, of which neonates account for about 38.5%-60% of all cases. Due to the immunosuppressive e...
Eligibility Criteria
Inclusion
- Case groups:
- KHE patients treated with sirolimus.
- After immunoglobulin and flow cytometry assays, as well as outpatient evaluation and assessment, those participants will be vaccinated with live attenuated vaccines or inactivated vaccines in a timely order according to the advice.
- Control groups:
- Healthy children with no immune deficiencies.
- Participants are vaccinated according to the National Immunization Program in a timely manner.
- Participants are matched to the case group according to age.
Exclusion
- HBsAg, HBeAg positive, or other active infectious diseases;
- History of immunodeficiency or low immunoglobulin levels;
- Autoimmune disease or fever during blood collection;
- Use of other medication or surgery;
- Suffering from other bleeding disorders;
- Suffering from other solid tumors or hematological tumors, etc.;
- Withdraw informed consent.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT05351216
Start Date
March 1 2021
End Date
March 1 2028
Last Update
June 27 2025
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, 201102