Actively Recruiting
Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2026-05-13
50
Participants Needed
13
Research Sites
676 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 2 years or older with arteriovenous malformations stage II, III, or IV (active or inactive, with or without bleeding)
- Signed informed consent by patients or parents for minors
- Effective contraception during the study and for 12 weeks after treatment for participants of childbearing potential
- Negative pregnancy blood test for women of childbearing age
You will not qualify if you...
- Chronic or acquired immunosuppression, including organ transplant recipients, hematopoietic stem cell recipients, or congenital immunodeficiency
- Chronic active infection with hepatitis B, hepatitis C, or HIV
- Pregnant or nursing women
- Allergy to macrolides, peanuts, or soy
- Hypersensitivity to sirolimus or its excipients
- Contraindications to MRI
- Leukopenia below 1,000/mm3
- Thrombocytopenia below 80,000/mm3
- Anemia with hemoglobin less than 9 g/dl
- Elevated liver transaminases greater than 2.5 times normal
- History of cancer within 2 years before inclusion
- Surgery within 2 months before inclusion
- Active viral or bacterial infection at inclusion
- Hypercholesterolemia over 7 mmol/l despite treatment
- Hyperlipidemia over 2 mmol/l despite treatment
- Uncontrolled diabetes
- Inability to follow the clinical study
- Persons under major guardianship or deprived of liberty
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Trial Site Locations
Total: 13 locations
1
UCL
Brussels, Belgium
Not Yet Recruiting
2
CHU Amiens
Amiens, France, 80000
Actively Recruiting
3
CHU Bordeaux
Bordeaux, France, 33000
Not Yet Recruiting
4
CHU Dijon
Dijon, France, 21000
Actively Recruiting
5
CHRU Lille
Lille, France, 59000
Not Yet Recruiting
6
HCL Lyon
Lyon, France, 69000
Actively Recruiting
7
APHM
Marseille, France, 13000
Not Yet Recruiting
8
CHU Montpellier
Montpellier, France, 34000
Not Yet Recruiting
9
CHU Nancy
Nancy, France, 54000
Not Yet Recruiting
10
CHU Nice
Nice, France, 06000
Not Yet Recruiting
11
APHP
Paris, France, 75000
Not Yet Recruiting
12
CHU Strasbourg
Strasbourg, France, 67000
Not Yet Recruiting
13
CHU Tours
Tours, France, 37000
Not Yet Recruiting
Research Team
B
Bernard DEVAUCHELLE, MD, PhD
CONTACT
S
Sylvie TESTELIN, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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