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Immunosuppression and caplacizumab with plasma infusion instead of plasma exchange for immune TTP

Efficacy and Safety of Immunosuppression, Caplacizumab and Plasma Infusion Without Therapeutic Plasma Exchange in Immune-mediated Thrombotic Thrombocytopenic Purpura: Multicentric Non-inferiority Single-arm Study

Not applicable Interventional University Hospital, Rouen · NCT06291025

This study tests whether adults with immune-mediated TTP can be treated safely and effectively with immunosuppression and caplacizumab plus plasma infusion without daily plasma exchange.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment131 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Rouen Academic / other
Drugs / interventionscaplacizumab, rituximab, chemotherapy, prednisone
Locations30 sites (Amiens and 29 other locations)
Trial IDNCT06291025 on ClinicalTrials.gov

What this trial studies

The study will treat adults presenting with clinical immune-mediated TTP using a regimen of immunosuppressive drugs, caplacizumab, and controlled plasma infusions while omitting therapeutic plasma exchange. The investigators previously reported that adding caplacizumab to immunosuppression and PEX improved outcomes and reduced the number and volume of exchanges in 90 patients. Because PEX is invasive and associated with catheter- and plasma-related complications, a PEX-free regimen could lessen procedural risk and the burden of care. The protocol leverages shorter courses of plasma infusion together with caplacizumab to limit fluid overload and will be conducted at multiple French university hospitals.

Who should consider this trial

Good fit: Adults (≥18 years) with a clinical diagnosis of immune-mediated TTP, marked thrombocytopenia (platelets ≤30 G/L) and serum creatinine ≤200 μmol/L who can provide informed consent are the intended participants.

Not a fit: Patients with non-immune thrombotic microangiopathies, severe renal impairment, urgent life-threatening presentations that require immediate plasma exchange, or contraindications to caplacizumab or plasma infusion are unlikely to benefit from this PEX-free approach.

Why it matters

Potential benefit: If successful, this approach could spare patients the invasive plasma exchange procedure, reduce catheter- and plasma-related complications, and shorten hospital stays.

How similar studies have performed: Previous work showed clear benefit when caplacizumab was added to immunosuppression plus plasma exchange, and older reports of plasma-infusion-only approaches showed some early improvement but were limited by fluid overload, making a fully PEX-free strategy novel and only partly tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Amiens and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Thrombotic Microangiopathies
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.