RecruitingPhase 2NCT02042326

Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

50 participants

Start Date

Sep 12, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of the study is to evaluate the efficacy and safety of sirolimus (oral form), to decrease the volume and symptoms due to superficial arteriovenous malformations (AVM). Sirolimus has properties that reduce the activity of the immune system (immunosuppressant), to fight against the proliferation of cancer cells (anti- tumor) and also reduce the proliferation of blood vessels (anti -vascular). Sirolimus is primarily used in transplant patients to prevent organ transplant rejection. Many animal and laboratory studies were carried out and demonstrate in particular the activity of sirolimus on vessels. It is this anti- vascular effect that could help treat arteriovenous malformations.


Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Sirolimus for people with arteriovenous malformations. The study is currently recruiting participants at 13 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSirolimus

For patients with swallowing problems, and for children under 6 years and / or who have an inability to swallow tablets, the 1mg/ml solution form should be used.


Locations(13)

UCL

Brussels, Belgium

CHU Amiens

Amiens, France

CHU Bordeaux

Bordeaux, France

CHU Dijon

Dijon, France

CHRU Lille

Lille, France

HCL Lyon

Lyon, France

APHM

Marseille, France

CHU Montpellier

Montpellier, France

CHU Nancy

Nancy, France

CHU Nice

Nice, France

APHP

Paris, France

CHU Strasbourg

Strasbourg, France

CHU Tours

Tours, France

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NCT02042326


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