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RECRUITING
NCT02042326
PHASE2

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

Sponsor: Centre Hospitalier Universitaire, Amiens

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2014-09-12

Completion Date

2027-09

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

DRUG

Sirolimus

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