Clinical Trial

Weekly Sirolimus Therapy

Recruiting Phase 2
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Summary
In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. The purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. Additionally, the study will evaluate patient satisfaction and identify adverse effects. Participants will be on the medication for 6 months with an option to continue after this time period.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2021-04-23; most recent amendment 2026-03-03.
Status change: Not Yet Recruiting → Recruiting 2021-05-22
Trial Details
NCT Number NCT04861064
Lead Sponsor Medical University of South Carolina
Conditions Venous Malformation, Lymphatic Malformation
Enrollment 24 participants
Start Date 2022-01-18
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-05