Different Doses of Sirolimus for the Maintenance Treatment of Kaposiform Hemangioendothelioma: a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to compare the efficacy and safety of different doses of sirolimus in the maintenance treatment of kaposiform hemangioendothelioma.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 14
Healthy Volunteers: f
View:
∙ Presenting a KHE with the following characteristics:
• Male and female;
• Between 0 and 14 years of age;
• Diagnosis of KHE as determined by:
‣ Biopsy;
⁃ Compatible MRI findings;
⁃ History and clinical features.
• Patients were required to have adequate liver, renal and bone marrow function, and absence of active infection
• Consent of parents (or the person with parental authority in families): signed and dated written informed consent.
Locations
Other Locations
China
West China Hospital of Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Yi Ji, MD, PhD
jijiyuanyuan@163.com
86 28 85423453
Backup
Siyuan Chen, MD, PhD
siy_chen@163.com
86 28 85422215
Time Frame
Start Date: 2022-04-05
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 30
Treatments
Experimental: Low dose of sirolimus
The plasma trough concentration of sirolimus is maintained within the range of 10-15 ng/ml by adjusting sirolimus dose, for 6 months. Then, The plasma trough concentration of sirolimus is maintained within the range of 5-8 ng/ml by adjusting sirolimus dose, for 6 months.
Active_comparator: Regular dose of sirolimus
Sirolimus The plasma trough concentration of sirolimus is maintained within the range of 10-15 ng/ml by adjusting sirolimus dose, for 1 year.
Related Therapeutic Areas
Sponsors
Leads: West China Hospital