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Landmark study questions blood thinner use in Behçet's clots

NCT ID NCT06780462

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 adding blood thinners (anticoagulants) to standard steroid treatment is better than steroids alone for deep vein clots in people with Behçet's syndrome. About 134 adults with a first or repeat clot will be randomly assigned to one of two groups. The goal is to see which approach prevents new clots and major bleeding more effectively over 6 months.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 134 people

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

Started

Jun 2025

Expected to finish

Jun 2028

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

18 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: 1. Age ≥ 18 years old 2. Diagnosis of BS according to the international criteria 3. First or recurrent deep venous thrombosis diagnosed on imaging (venous ultrasonography , and/or Angio CT scan and/or angio MRI) 4. Written inform consent 5. Women of childbearing potential (WOCBP) are required to have a negative pregnancy test before treatment and must agree to maintain during treatment highly effective contraception (ie, abstinence, combined estrogen- and progestogen- containing hormonal contraception, ovulation inhibitors (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner). 6. Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study Exclusion Criteria: 1. Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…) 2. Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants 3. Isolated superficial thrombosis without concomitant deep venous thrombosis. 4. Pregnancy or lactation 5. Have been taking an oral daily dose of a glucocorticoid of more than 20 mg prednisone equivalent for more than 6 weeks continuously prior to the inclusion visit or taking more than 4000 mg methylprednisolone 4 weeks prior to the inclusion visit 6. Have been taking anti-coagulation therapy for more than 4 weeks prior to inclusion 7. Severe chronic renal (creatinine clearance \<30ml/min/1,73m2) or liver insufficiency associated with coagulopathy 8. Platelet count \< 50 x 103/mm3 9. Change in the treatment with systemic biologic therapy or immunosuppressant therapy dose 1 month prior to inclusion visit. 10. Contraindication to investigational medicinal products (Corticosteroids and direct oral anticoagulant (Rivaroxaban)) 11. Participation to another interventional clinical trial or being in the exclusion period at the end of a previous study

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Conditions

The condition(s) this trial relates to.

Behcet disease

As listed by the trial registrant

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

Behcet syndrome

How to take part

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

  1. The places running it

    17 sites. 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

  • Ambroise Paré hospital AP-HP

    RECRUITING

    Boulogne-Billancourt, France

  • CHRU DE Nancy Hôpitaux de Brabois

    RECRUITING

    Nancy, France

  • CHU BORDEAUX Hôpital Saint-André

    RECRUITING

    Bordeaux, France

  • CHU Bordeaux- GHU SUD hôpital Haut-Lévêque

    RECRUITING

    Pessac, France

  • CHU Caen

    RECRUITING

    Caen, France

  • CHU DE ROUEN, Hôpital CHARLES NICOLLE

    RECRUITING

    Rouen, France

  • Centre Hospitalier de Melun

    RECRUITING

    Melun, France

  • Chu de Grenoble

    RECRUITING

    Grenoble, France

  • Hcl, Hopital de La Croix Rousse

    RECRUITING

    Lyon, France

  • Hopital Européen Georges Pompidou AP-HP

    RECRUITING

    Paris, France

  • Hopital Henri Mondor AP-HP

    RECRUITING

    Créteil, France

  • Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, France

  • Hôpital Hôtel-Dieu

    RECRUITING

    Nantes, France

  • Hôpital Lariboisière AP-HP

    RECRUITING

    Paris, France

  • Hôpital Saint Antoine AP-HP

    RECRUITING

    Paris, France

  • Hôpital Tenon AP-HP

    RECRUITING

    Paris, France

  • La Pitié Salpetriere hospital

    RECRUITING

    Paris, France

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