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Could a needle replace a machine? new study aims to simplify lifesaving iTTP treatment

NCT ID NCT06291025

Disease control Sponsor: University Hospital, Rouen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a simpler treatment for immune thrombotic thrombocytopenic purpura (iTTP) works as well as the standard approach. Instead of daily plasma exchange (an invasive procedure), patients receive plasma infusions, immune-suppressing drugs, and caplacizumab. The goal is to reduce complications and burden while still controlling the disease. About 131 adults with iTTP will take part.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 131 people

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

Started

Apr 2024

Expected to finish

Aug 2026

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: * Adult patient ≥ 18 years; * Clinical diagnosis of iTTP based on standard clinical and laboratory criteria (French Score ≥ 2): i.e., thrombotic microangiopathy syndrome with platelet count ≤ 30 G/L and serum creatinine ≤ 200 μmol/L; it is not necessary to have the laboratory result confirming the severe ADAMTS13 deficiency for inclusion of patient \[32\] (For patient with previous TTPflare, French score can be \< 2); * Patient having read and understood the information letter and signed the Informed Consent Form. If the patient is unable to express his consent, the consent will be signed by his representative ((1) the trusted person, or failing that, (2) a family member, or (3) a close relative of the person concerned). In this case, consent to continue the study will subsequently be requested from the patient (article L1122-1-1 of the CSP); * Patient affiliated with, or beneficiary of a social security (national health insurance) plan; * For women: * Women of childbearing potential : * Effective contraception according to WHO definition (estrogen-progestin or intrauterine device or tubal ligation) since at least 1 month and; * Negative blood pregnancy test; * Women surgically sterile (absence of ovaries and/or uterus); * Postmenopausal women (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit). Exclusion Criteria: * Platelet count \> 100 G/L before plasma treatment; * Patients with a French score \< 2 (a serum creatinine level \> 200 μmol/L and/or with a platelet count \> 30 G/L), in order to exclude possible cases of hemolytic uremic syndrome (except for patient with previous TTPflare, French score can be \< 2); * Other known causes of cytopenias and/or organ failure including but not limited to: uncontrolled cancer, chemotherapy, transplant, drugs, HIV at AIDS stage; * Patients with a severe neurological disorder i.e. seizure, coma, focal deficiency, trouble of consciousness; * Pregnant women (positive result from a blood pregnancy test) or patients with an imminent project of pregnancy; breastfeeding women (due to lack of pharmacological data for caplacizumab during pregnancy and breastfeeding); * Weight \> 100KG; * Congenital TTP; * Clinically significant active bleeding or high risk of bleeding (excluding thrombocytopenia); * Chronic treatment with anticoagulant that cannot be interrupted safely, including but not limited to: vitamin K antagonists, direct oral anticoagulant, low molecular weight heparin or heparin; * Malignant hypertension; * Contra-indication to CABLIVI 10 mg powder and solvent for solution for injection: hypersensitivity to caplacizumab or to any of the excipients; * Contra-indication to Plasma treatment; * Contra-indication to corticosteroid (= ((methyl)prednisone or (methyl)prednisolone)) or excipients; * Contra-indication to rituximab or excipients and to its premedication; * Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision); * Participation in another drug interventional clinical trial within 30 days prior to inclusion and during the study.

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Conditions

The condition(s) this trial relates to.

acquired thrombotic thrombocytopenic purpura thrombotic microangiopathy

As listed by the trial registrant

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

Thrombotic microangiopathies

How to take part

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

  1. The places running it

    30 sites in 3 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

  • Ap-Hm La Conception

    RECRUITING

    Marseille, 13005, France

  • Ap-Hp Pitie Salpetriere

    NOT_YET_RECRUITING

    Paris, 75651, France

  • Ap-Hp Saint Louis

    RECRUITING

    Paris, 75010, France

  • Ap-Hp St Antoine

    RECRUITING

    Paris, 75571, France

  • CH PAU

    NOT_YET_RECRUITING

    Pau, 64046, France

  • CHU NICE

    RECRUITING

    Nice, 06200, France

  • Ch Saint-Nazaire

    NOT_YET_RECRUITING

    Saint-Nazaire, 44606, France

  • Ch Valenciennes

    RECRUITING

    Valenciennes, 59322, France

  • Chru Besanon

    RECRUITING

    Besançon, 25030, France

  • Chu Amiens

    RECRUITING

    Amiens, 80054, France

  • Chu Angers

    RECRUITING

    Angers, 49933, France

  • Chu Bobigny

    RECRUITING

    Bobigny, 93000, France

  • Chu Bordeaux

    RECRUITING

    Bordeaux, 33076, France

  • Chu Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, 63003, France

  • Chu Edouard Herriot

    RECRUITING

    Lyon, 69003, France

  • Chu Lille

    RECRUITING

    Lille, 59037, France

  • Chu Limoges

    NOT_YET_RECRUITING

    Limoges, 87042, France

  • Chu Martinique

    NOT_YET_RECRUITING

    Fort-de-France, 97261, Martinique

  • Chu Montpellier

    RECRUITING

    Montpellier, 34295, France

  • Chu Nancy

    RECRUITING

    Nancy, 54500, France

  • Chu Nantes

    RECRUITING

    Nantes, 44093, France

  • Chu Nimes

    RECRUITING

    Nîmes, 30029, France

  • Chu Reims

    RECRUITING

    Reims, 51092, France

  • Chu Reunion Sud

    RECRUITING

    Saint-Pierre, 97448, Reunion

  • Chu Rouen

    RECRUITING

    Rouen, 76031, France

  • Chu Strasbourg

    RECRUITING

    Strasbourg, 67091, France

  • Chu Toulouse

    RECRUITING

    Toulouse, 31000, France

  • Chu Tours

    NOT_YET_RECRUITING

    Tours, 37044, France

  • Hopital Jean Verdie

    RECRUITING

    Bondy, 93140, France

  • Reunion Nord

    RECRUITING

    Saint-Denis, 97400, Reunion

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