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Study on Sirolimus and Prednisolone for Treating Superficial Arteriovenous Malformations in Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of a medication called sirolimus, which is marketed under the name Rapamune, in treating a condition known as superficial arteriovenous malformations. These malformations are abnormal connections between arteries and veins that can cause various symptoms and complications. The purpose of the study is to evaluate whether sirolimus can help reduce the size of these malformations.

Participants in the study will take sirolimus in the form of coated tablets. The study will also involve the use of another medication, prednisolone metasulfobenzoate sodium, which is available as an orodispersible tablet under the name SOLUPRED. The study will compare the effects of sirolimus with those of a placebo to determine its effectiveness. The main goal is to see if there is a reduction in the size of the malformations over the course of the study.

The study will take place over a period of time, with assessments at various intervals to monitor changes in the malformations. Participants will be observed for any changes in the size of the malformations, and the results will be analyzed to determine the effectiveness of the treatment. The study aims to provide valuable information on the potential benefits of sirolimus for individuals with superficial arteriovenous malformations.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the stage of the condition and ensuring all necessary consent forms are signed.

  2. Step 2

    Medication administration

    The treatment involves taking sirolimus (Rapamune) in the form of 1 mg coated tablets. The medication is taken orally. The exact dosage and frequency will be determined by the study team based on individual needs.

    Additionally, prednisolone metasulfobenzoate sodium is administered in the form of orodispersible tablets, available in 20 mg and 5 mg doses. These are also taken orally. The dosage and frequency will be specified by the study team.

  3. Step 3

    Treatment monitoring

    Regular monitoring is conducted to assess the treatment's effectiveness. This includes evaluations at three, six, and nine months to track changes in the condition.

    The primary goal is to achieve a reduction in the volume of the malformation by at least 30% within the first year, as measured by specific imaging techniques.

  4. Step 4

    Ongoing assessments

    Throughout the study, ongoing assessments are performed to ensure the safety and effectiveness of the treatment. Adjustments to the treatment plan may be made based on these assessments.

  5. Step 5

    Study completion

    The study is expected to conclude by September 12, 2026. At the end of the study, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

7 criteria

  • Patients must be adults, adolescents, or children over 2 years old.
  • Patients should have a condition called **superficial arteriovenous malformations**. This is a problem with blood vessels where they are not formed correctly.
  • Patients should be in stage II+, III, or IV according to the **Schöbinger classification**. This is a way to describe how advanced the condition is.
  • The condition can be either getting worse or staying the same, with or without bleeding issues.
  • Patients or their parents (if the patient is a minor) must sign a consent form. This form shows they understand the risks and benefits of the study.
  • Patients must use effective birth control during the study and for up to 12 weeks after the treatment ends.
  • Women who can have children must have a negative pregnancy test before joining the study. This test checks for a hormone called **β-HCG** in the blood, which indicates pregnancy.

Who cannot join the trial?

3 criteria

  • Patients with medical conditions other than superficial arteriovenous malformations cannot participate. This condition involves abnormal connections between arteries and veins near the surface of the skin.
  • Patients who are not within the specified age range cannot participate. The study includes specific age groups, so only those who fit these age categories are eligible.
  • Patients who are part of a vulnerable population cannot participate. This means individuals who might need special protection or care are not included in the study.
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Investigated drugs

Sirolimus (Rapamune) is a medication used in this clinical trial to treat superficial arteriovenous malformations. It works by slowing down the growth of abnormal blood vessels. This medication is being evaluated for its ability to reduce the size of these malformations, which are abnormal connections between arteries and veins.

What is already known about the treatment

Sirolimus (Rapamune) – This medication is administered orally in the form of tablets or a liquid solution. It is currently being studied for its effectiveness in treating superficial arteriovenous malformations, which are abnormal connections between arteries and veins. Sirolimus is primarily used to reduce the size of these malformations by targeting specific pathways in the body. It works by inhibiting a protein called mTOR, which plays a role in cell growth and proliferation. Sirolimus is classified as an immunosuppressant and is commonly used to prevent organ transplant rejection, but its potential in treating vascular malformations is under investigation.

Investigated diseases

Superficial Arteriovenous Malformations – These are abnormal connections between arteries and veins that occur near the surface of the skin. They bypass the normal capillary system, leading to a tangle of blood vessels. Over time, these malformations can grow and change, potentially causing swelling or a noticeable mass. They may also lead to skin discoloration or warmth over the affected area. As they progress, they can sometimes cause discomfort or pain due to increased blood flow and pressure. The condition is typically identified through imaging studies that reveal the characteristic network of vessels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516001-23-00Estimated enrolment50 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie

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