NCT05351216 The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma
| NCT ID | NCT05351216 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Kaposiform Hemangioendothelioma |
| Study Type | OBSERVATIONAL |
| Enrollment | 174 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 174 participants in total. It began in 2021-03-01 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 vaccination in a timely manner during the administration of sirolimus in children with KHE. To search for back-up plans for vaccination regimens for KHE patients taking sirolimus in children who do not respond to primary vaccination.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Kai Li, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT05351216 clinical trial?
This trial is open to participants of all sexes, up to 12 Years, studying Kaposiform Hemangioendothelioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05351216 currently recruiting?
Yes, NCT05351216 is actively recruiting participants. Contact the research team at likai2727@163.com for enrollment information.
Where is the NCT05351216 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05351216 clinical trial?
NCT05351216 is sponsored by Children's Hospital of Fudan University. The principal investigator is Kai Li, PhD at Children's Hospital of Fudan University. The trial plans to enroll 174 participants.