Low- vs High-Dose Sirolimus With Prednisolone for KHE and KMP
Recruiting
Phase 2
Phase 3
Interventional Study
Kaposiform Hemangioendothelioma (KHE)
Kasabach Merritt Phenomenon
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Day – 18
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 76 (estimated)
- Sponsor
- Yi Ji · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
This randomized clinical trial evaluates if low-dose sirolimus (target trough 4-8 ng/mL) combined with prednisolone is noninferior in efficacy but superior in safety compared to standard high-dose sirolimus (target trough 10-15 ng/mL) combined with prednisolone in pediatric patients with kaposiform hemangioendothelioma and Kasabach-Merritt phenomenon (KHE with KMP), with participants randomized 1:…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* Presenting a KHE with the following characteristics:
1. Clinical features and histological findings consistent with progressive, non-resectable KHE associated with KMP.
2. Patients must be 0 - 18 years of age at the time of study entry.
3. Without functional impairment …
Contacts