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Could a transplant drug shrink dangerous blood vessel tangles?

NCT ID NCT02042326

Disease control Sponsor: Centre Hospitalier Universitaire, Amiens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether sirolimus, a drug used to prevent organ rejection, can shrink severe arteriovenous malformations (AVMs) and ease symptoms. About 50 people aged 2 and older with advanced AVMs will take the drug for a year. The goal is to see if the drug reduces AVM size by at least 30% and stops it from growing, but participants may need ongoing treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2014

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients (adults, adolescents and children older than 2 years), with arteriovenous malformation stage II + III or IV (according to Schöbinger's classification) : active or quiescent, marked or not by hemorrhagic phenomena. * Patients (parents for minors) must sign a consent form established after clear information risks and expected benefits of the study. * Patients (major and minor of childbearing age) must have effective contraception during the study period and continuing until 12 weeks after the end of treatment * Negative pregnancy blood test for women of childbearing age. Exclusion Criteria: * Chronic or acquired immunosuppression : * patients with transplanted organ or who received a hematopoietic stem cell * patient with congenital immunodeficiency * Patients implanted with chronic active infection associated with hepatitis B , hepatitis C or HIV * Pregnant or nursing woman. * Allergy to macrolides * Allergy to peanut or soya * Hypersensitivity to " Sirolimus " or any of the excipients of the investigational product * Contraindications to performing an MRI * Leukopenia below 1 000 /mm3 * Thrombocytopenia lower to 80,000 /mm3 * Anemia with Hb \< 9 g/dl * Elevated transaminase \> 2.5 N * History of cancer less than two years before the inclusion * Surgery older than 2 months before inclusion * Active infection (viral and bacterial ) on the date of inclusion * Hypercholesterolemia \> 7 mmol / l despite appropriate medical treatment * Hyperlipidemia \> 2 mmol / l despite appropriate medical treatment * Uncontrolled diabetes * Patients unable to follow a clinical study * Major under guardianship, persons deprived of their liberty

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Conditions

The condition(s) this trial relates to.

arteriovenous hemangioma/malformation arteriovenous malformations of the brain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arteriovenous malformations

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHM

    NOT_YET_RECRUITING

    Marseille, 13000, France

  • APHP

    NOT_YET_RECRUITING

    Paris, 75000, France

  • CHRU Lille

    NOT_YET_RECRUITING

    Lille, 59000, France

  • CHU Amiens

    RECRUITING

    Amiens, 80000, France

  • CHU Bordeaux

    NOT_YET_RECRUITING

    Bordeaux, 33000, France

  • CHU Dijon

    RECRUITING

    Dijon, 21000, France

  • CHU Montpellier

    NOT_YET_RECRUITING

    Montpellier, 34000, France

  • CHU Nancy

    NOT_YET_RECRUITING

    Nancy, 54000, France

  • CHU Nice

    NOT_YET_RECRUITING

    Nice, 06000, France

  • CHU Strasbourg

    NOT_YET_RECRUITING

    Strasbourg, 67000, France

  • CHU Tours

    NOT_YET_RECRUITING

    Tours, 37000, France

  • HCL Lyon

    RECRUITING

    Lyon, 69000, France

  • UCL

    NOT_YET_RECRUITING

    Brussels, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.