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Blood thinner breakthrough could stop clots in rare anemia

NCT ID NCT05089227

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 taking blood thinners for 12 weeks can prevent dangerous blood clots in people with autoimmune hemolytic anemia (AIHA), a rare disease where the immune system destroys red blood cells. About 72 adults with newly diagnosed or relapsed AIHA will receive either standard care or extended blood-thinner treatment. The goal is to see if longer prevention reduces the high risk of clots during the first three months after diagnosis or relapse.

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 72 people

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

Started

Feb 2022

Expected to finish

Aug 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: * Patient aged ≥ 18 years * Patient with a diagnosis of primary or secondary autoimmune hemolytic anemia (AIHA) (infections, hematologic diseases, systemic diseases), according to the following criteria: * Hemoglobin \<12 g/dL * and decreased haptoglobin (\<0.4 g/L) * and positive direct antiglobulin test (direct Coombs test) (IgG +/- C3d) * Patient newly diagnosed or relapse * Patient with an estimated life expectancy of more than 6 months * Patient who provided free, written and informed consent Exclusion Criteria: * Patients with immediate symptomatic VTE, confirmed by appropriate complementary examinations (venous Doppler of the lower limbs, thoracic angioscanner or pulmonary scintigraphy). * Patients on curative anticoagulation (venous thromboembolic disease, atrial fibrillation) * Patient on dual antiaggregation treatment * Patient with active bleeding * Patient with a known condition or lesion at risk of bleeding * Patient with ischemic stroke with hemorrhagic transformation within 6 months prior to inclusion * Patient on preventive anticoagulation for 14 days or more * Patient with a contraindication to apixaban: * Known hypersensitivity to the molecule or to any of the excipients,, * thrombocytopenia \<100 G/L, * kidney failure (glomerular filtration rate \< 30 ml/min/1.73m²) * Active liver disease (liver failure defined as Factor V \<50% or INR \>1.5, ALT elevation \>2 times the upper limit of normal) * Patients receiving concomitant CYP3A4 inducers (rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) or CYP3A4 inhibitors (azole antifungals, HIV protease inhibitors), if these therapies cannot be discontinued or modified * Patients with a contraindication to enoxaparin: * allergy to the drug * history of heparin-induced thrombocytopenia * Patient with cold agglutinin-related AHAI (C3d-positive ADT alone with identification of cold agglutinins) * Patient with severe disorders of hemostasis: * hypofibrinogenemia \< 2 g/L, * disseminated intravascular coagulation (APTT prolongation\>1.2, and PT\<50%, and thrombocytopenia\<100 G/L, and D-Dimer \>500 µg/L) * hemophilia * Patient whose clinical condition requires hospitalization in an intensive care unit * Patient who has already participated in the study * Patient not affiliated to national health insurance * Patient under legal protection (curatorship, guardianship) * Patient subject to a measure of legal protection * Pregnant, parturient or breastfeeding women * Patient with physiological capacity to procreate (having had her first menstrual period and not menopausal and not presenting permanent sterility (hysterectomy, bilateral salpingectomy, bilateral oophorectomy)) and unable to have effective contraception (i.e., provided by an estrogen-progestin oral contraceptive or progestogen, a contraceptive implant, an intrauterine device or a tubal ligation) * Patient of legal age who is unable to provide consent

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Chu Dijon Bourgogne

    RECRUITING

    Dijon, 21000, France

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