Status:
RECRUITING
Weekly Sirolimus Therapy
Lead Sponsor:
Medical University of South Carolina
Conditions:
Venous Malformation
Lymphatic Malformation
Eligibility:
All Genders
2+ years
Phase:
PHASE2
Brief 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 severa...
Eligibility Criteria
Inclusion
- Patient 2 years of age and older
- Venous, lymphatic, or venolymphatic malformations
Exclusion
- Children with contraindication to use of sirolimus
- Children with history of transplant
- Children with a history of natural immunodeficiency
- Children with a history of artificially induced immunodeficiency
- Children with a history of a serious or life-threatening infection
- Children taking CYP3A4 inhibiting medications
- Children taking strong CYP3A4 inducers to avoid subtherapeutic dosing/exposure.
- Inability or unwillingness of subject or legal guardian/representative to give informed consent
- Women that are or may become pregnant o Sirolimus is a Pregnancy Category C drug. No randomized controlled studies have been done on pregnant women. Women of childbearing potential must be on effective contraception prior to, during, and for 12 weeks following sirolimus therapy.
Key Trial Info
Start Date :
January 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04861064
Start Date
January 18 2022
End Date
June 1 2026
Last Update
March 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29403