Guided Discontinuation Versus Maintenance Treatment of Sirolimus in Pediatric Patients With Kapos… (NCT04448873) | Clinical Trial Compass
CompletedPhase 4
Guided Discontinuation Versus Maintenance Treatment of Sirolimus in Pediatric Patients With Kaposiform Hemangioendothelioma
China30 participantsStarted 2020-07-01
Plain-language summary
This randomized controlled trial aims to compare guided discontinuation with maintenance treatment of sirolimus in pediatric patients with KHE.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant diagnosed with KHE with or without KMP
* Participant age 0-12 years
* Participant with detailed medical records of the disease at the time of screening
* Participant with at least two years of remission of KHE and no previous toxicity or adverse events
* Participant with normal liver and kidney function
* Participant with signed and dated informed consent from the guardian(s)
Exclusion Criteria:
* Participant with other hematological diseases
* Participant with other solid tumor
* Participant with general disease such as hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney dysfunction, and cardiopulmonary insufficiency.
* Participant with infectious diseases
* Unwilling participant
What they're measuring
1
Remission of KHE and no use of sirolimus at one year follow-up.