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New treatment option for Venous Malformation
Official title Weekly Sirolimus Therapy
ClinicalTrials.gov ID: NCT04861064
What this study is testing
What is Sirolimus?
Sirolimus is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for venous malformation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Patient 2 years of age and older
- Venous, lymphatic, or venolymphatic malformations
You likely can't join if
- 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
See the full eligibility criteria
- Patient 2 years of age and older
- Venous, lymphatic, or venolymphatic malformations
- 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 assigned by chance controlled studies have been done on pregnant women. Women of childbearing potential must be on effective...
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.