Thrombotic MicroangiopathiesPEX-FREENCT06291025
Efficacy and Safety of Immunosuppression, Caplacizumab and Plasma Infusion Without Therapeutic Plasma Exchange in Immune-mediated Thrombotic Thrombocytopenic Purpura
A study testing PEX-FREE in people with Thrombotic Microangiopathies, run by University Hospital, Rouen at 30 sites in 3 countries.
Trial summary
Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe, autoantibody-mediated deficiency of ADAMTS13 leading to an accumulation of ultra-large von Willebrand factor multimers in plasma and finally to microthrombi in blood vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombotic Microangiopathies
- What is being tested?
- PEX-FREE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 10 Apr 2024to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 :
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
30 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
30 sites in 3 countries
France27 sites, 27 recruiting
- Recruiting
Chu Amiens
Amiens, 80054
Coralie Poulain, Dr, 03 22 45 62 19, poulain.coralie@chu-amiens.fr
Coralie Poulain, Dr
- Recruiting
Chu Angers
Angers, 49933
Jean-François Augusto, Dr, 02 41 35 39 34, jfaugusto@chu-angers.fr
Jean-François Augusto, Dr
- Recruiting
Chru Besanon
Besançon, 25030
Anne Rumpler, Dr, 03 81 66 84 07, arumpler@chu-besancon.fr
Anne Rumpler, Dr
- Recruiting
Chu Bobigny
Bobigny, 93000
Julien Schmidt, Dr, 06 33 26 71 10, julien.schmidt@aphp.fr
Julien Schmidt, Dr
- Recruiting
Hopital Jean Verdie
Bondy, 93140
Laurent Gilardin, Dr, 01 48 02 83 67, laurent.gilardin@aphp.fr
Laurent Gilardin, Dr
- Recruiting
Chu Bordeaux
Bordeaux, 33076
Yahsou Delmas, Dr, 05 56 79 58 31, yahsou.delmas@chu-bordeaux.fr
Yahsou Delmas, Dr
- Recruiting
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Virginie Rieu, Dr, 04 73 75 00 85, vrieu@chu-clermontferrand.fr
Virginie Rieu, Dr
- Recruiting
Chu Lille
Lille, 59037
François Provot, Dr, 03 20 44 50 00, francois.provot@chru-lille.fr
François Provot, Dr
- Not yet recruiting
Chu Limoges
Limoges, 87042
Zhour Elouafi, Dr, Zhour.ELOUAFI@chu-limoges.fr
Zhour Elouafi, Dr
- Recruiting
Chu Edouard Herriot
Lyon, 69003
Manon Marie, Dr, 04 72 11 76 78, manon.marie@chu-lyon.fr
Manon Marie, Dr
- Recruiting
Ap-Hm La Conception
Marseille, 13005
Pascale Poullin, Dr, 04 91 38 39 24, pascale.poullin@ap-hm.fr
Pascale Poullin, Dr
- Recruiting
Chu Montpellier
Montpellier, 34295
Kada Klouche, Pr, 04 67 33 77 36, k-klouche@chu-montpellier.fr
Kada Klouche, Dr
- Recruiting
Chu Nancy
Nancy, 54500
Pierre Perez, Dr, 03 83 15 74 36, p.perez@chru-nancy.fr
Pierre Perez, Dr
- Recruiting
Chu Nantes
Nantes, 44093
Emmanuel Canet, Dr, emmanuel.canet@chu-nantes.fr
Emmanuel Canet, Dr
- Recruiting
CHU NICE
Nice, 06200
Lucas Morand, Dr, 04 92 03 55 10, morand.l@chu-nice.fr
Lucas Morand, Dr
- Recruiting
Chu Nimes
Nîmes, 30029
Olivier Moranne, Dr, +33 04 66 68 32 56, Olivier.MORANNE@chu-nimes.fr
Olivier Moranne, Dr
- Recruiting
Ap-Hp Saint Louis
Paris, 75010
Eric Mariotte, Dr, +33 1 42 49 94 19, eric.mariotte@aphp.fr
Eric Mariotte, Dr
- Recruiting
Ap-Hp St Antoine
Paris, 75571
Paul Coppo, Pr, 01 49 28 26 21, paul.coppo@aphp.fr
Paul Coppo, Pr
- Not yet recruiting
Ap-Hp Pitie Salpetriere
Paris, 75651
Samir Saheb, Dr, 01.42.16.13.70, samir.saheb@aphp.fr
Samir Saheb, Dr
- Not yet recruiting
CH PAU
Pau, 64046
Laure Burguet, Dr, Laure.BURGUET@ch-pau.fr
Laure Burguet, Dr
- Recruiting
Chu Reims
Reims, 51092
Alain Wynckel, Dr, 03 26 78 76 31, awynckel@chu-reims.fr
Alain Wynckel, Dr
- Recruiting
Chu Rouen
Rouen, 76031
Ygal Benhamou, Pr, 02 32 88 90 03, ygal.benhamou@chu-rouen.fr
Ygal Benhamou, Pr
- Not yet recruiting
Ch Saint-Nazaire
Saint-Nazaire, 44606
François Perrin, Pr, 02 72 27 80 38, f.perrin@ch-saintnazaire.fr
François Nazaire, Pr
- Recruiting
Chu Strasbourg
Strasbourg, 67091
Thierry Krummel, Dr, Thierry.KRUMMEL@chru-strasbourg.fr
Thierry Krummel, Dr
- Recruiting
Chu Toulouse
Toulouse, 31000
Stanisla Faguer, Pr, 05-61-32-32-88, Faguer.s@chu-toulouse..fr
Stanislas Faguer, Pr
- Not yet recruiting
Chu Tours
Tours, 37044
Charlotte Salmon, Dr, 0247 473 855, Charlotte.salmon@med.univ-tours.fr
Charlotte Salmon, Dr
- Recruiting
Ch Valenciennes
Valenciennes, 59322
Claire Cartery, Dr, 03 27 14 36 48, cartery-c@ch-valenciennes.fr
Claire Cartery, Dr
Reunion2 sites, 2 recruiting
- Recruiting
Reunion Nord
Saint-Denis, 97400
Ludovic Di Ascia, Dr, 0262 90 55 50, ludovic.di-ascia@chu-reunion.fr
Ludovic Di Ascia, Dr
- Recruiting
Chu Reunion Sud
Saint-Pierre, 97448
Patricia Zunic, Dr, + 262 262 359 990, patricia.zunic@chu-reunion.fr
Patricia Zunic, Dr
Martinique1 site, 1 recruiting
- Not yet recruiting
Chu Martinique
Fort-de-France, 97261
Christophe Deligny, Dr, 05 96 55 22 55, christophe.deligny@chu-martinique.fr
Christophe Deligny, Dr
About this study
Official title: 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
Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe, autoantibody-mediated deficiency of ADAMTS13 leading to an accumulation of ultra-large von Willebrand factor multimers in plasma and finally to microthrombi in blood vessels. The current standard of care of iTTP consists in the triple association of daily plasma exchange (PEX, 60 ml/kg/day), immunosuppressive agents and anti-adhesive treatment (Caplacizumab). Our group recently reported the outcome of 90 patients with iTTP treated with this triple association and when compared to historical patients, the triplet regimen prevented death, refractoriness and exacerbations. Likewise, plasma volumes were reduced by 2 to 3-fold and the median number of PEX sessions could be reduced from 13 to 6. PEX is an invasive and time-consuming procedure, associated with catheter and plasma-related complications ranging from 22% to 30%. Consequently, to alleviate the burden of care in iTTP, using a regimen without PEX would represent a major and topical goal. Attempts to treat patients with plasma infusion (PI) without PEX were previously reported and provided evidence that large volumes of PI (20-30 ml/kg/day) improved the initial outcome of iTTP. However, fluid overload occurred in most cases after 5-7 days, limiting the feasibility of this strategy. Nevertheless, the recent availability of caplacizumab opens the perspective of treating patients with plasma for a shorter period. Recently, strategies without PEX have been carried out in Jehovah's Witnesses with iTTP [5]. Impressively, improvement was rapid and comparable to those provided with a standard PEX-based treatment. Additionally, a treatment combining caplacizumab and immunosuppression only was successfully performed in six iTTP patients with severe neurologic and/or cardiac involvement. The rapid and durable improvement provides evidence that a regimen without plasma seems feasible. However, it's considered that robust data are still lacking to completely remove plasmatherapy from iTTP management. Based on these statements, the objective is to address the efficacy and safety of a PEX-free regimen, combining PI only (15 ml/kg/day), corticosteroids/rituximab, and caplacizumab.
Read the detailed description
Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe, autoantibody-mediated deficiency of ADAMTS13 leading to an accumulation of ultra-large von Willebrand factor multimers in plasma and finally to microthrombi in blood vessels. The current standard of care of iTTP consists in the triple association of daily plasma exchange (PEX, 60 ml/kg/day), immunosuppressive agents and anti-adhesive treatment (Caplacizumab). Our group recently reported the outcome of 90 patients with iTTP treated with this triple association and when compared to historical patients, the triplet regimen prevented death, refractoriness and exacerbations. Likewise, plasma volumes were reduced by 2 to 3-fold and the median number of PEX sessions could be reduced from 13 to 6. PEX is an invasive and time-consuming procedure, associated with catheter and plasma-related complications ranging from 22% to 30%. Consequently, to alleviate the burden of care in iTTP, using a regimen without PEX would represent a major and topical goal. Attempts to treat patients with plasma infusion (PI) without PEX were previously reported and provided evidence that large volumes of PI (20-30 ml/kg/day) improved the initial outcome of iTTP. However, fluid overload occurred in most cases after 5-7 days, limiting the feasibility of this strategy. Nevertheless, the recent availability of caplacizumab opens the perspective of treating patients with plasma for a shorter period. Recently, strategies without PEX have been carried out in Jehovah's Witnesses with iTTP [5]. Impressively, improvement was rapid and comparable to those provided with a standard PEX-based treatment. Additionally, a treatment combining caplacizumab and immunosuppression only was successfully performed in six iTTP patients with severe neurologic and/or cardiac involvement. The rapid and durable improvement provides evidence that a regimen without plasma seems feasible. However, it's considered that robust data are still lacking to completely remove plasmatherapy from iTTP management. Based on these statements, the objective is to address the efficacy and safety of a PEX-free regimen, combining PI only (15 ml/kg/day), corticosteroids/rituximab, and caplacizumab.
- Conditions
- Thrombotic Microangiopathies
- Being tested
- PEX-FREE
- Medical subject headings
- Thrombotic Microangiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEX-FREEProcedure or surgery
Also called PEX-FREE procedure
The study/experimental procedure consists in replacing daily PEX with daily plasma infusions (ie. Quarantine fresh frozen plasma (PFC-Se), solvent detergent/viral inactivated plasma (PFC-SD = OCTAPLASLG) or amotosalen-inactivated plasma (PFC-IA); volume 15mL/kg/day).
| Study group | Role | What they receive |
|---|---|---|
| PEX-FREE | Experimental | Replacing daily PEX with daily plasma infusions (ie. Quarantine fresh frozen plasma (PFC-Se), solvent detergent/viral inactivated plasma (PFC-SD = OCTAPLASLG) or amotosalen-inactivated plasma (PFC-IA); volume 15mL/kg/day). Receives: Procedure: PEX-FREE |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of a PEX-FREE regimen in adults with iTTP as assessed by the proportion of participants day-30 post-plasma therapy death, refractoriness, exacerbation or an ADAMTS13 activity < 20%.
Complete plasma infusion treatment and clinical remission at day 30 defined by both lack of occurrence of any of the four events during the 30 days post plasma infusion procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start10 Apr 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombotic MicroangiopathiesStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This trial is prospective, non-comparative, non-inferiority, single-arm, multicentric, national.
- Masking
- None (open label)
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291025
- Sponsor's protocol ID
- 2021/0374/HP
- Acronym
- PEX-FREE
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06291025
- Acronym / sponsor ID
- PEX-FREE / 2021/0374/HP
- Conditions
- Thrombotic Microangiopathies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe, autoantibody-mediated deficiency of ADAMTS13 leading to an accumulation of ultra-large von Willebrand factor multimers in plasma and finally to microthrombi in blood vessels. The current standard of care of iTTP consists in the triple association of daily plasma exchange (PEX, 60 ml/kg/day), immunosuppressive agents and anti-adhesive treatment (Caplacizumab). Our group recently reported the outcome of 90 patients with iTTP treated with this triple association and when compared to historical patients, the triplet regimen prevented death, refractoriness and exacerbations. Likewise, plasma volumes were reduced by 2 to 3-fold and the median number of PEX sessions could be reduced from 13 to 6. PEX is an invasive and time-consuming procedure, associated with catheter and plasma-related complications ranging from 22% to 30%. Consequently, to alleviate the burden of care in iTTP, using a regimen without PEX would represent a major and topical goal. Attempts to treat patients with plasma infusion (PI) without PEX were previously reported and provided evidence that large volumes of PI (20-30 ml/kg/day) improved the initial outcome of iTTP. However, fluid overload occurred in most cases after 5-7 days, limiting the feasibility of this strategy. Nevertheless, the recent availability of caplacizumab opens the perspective of treating patients with plasma for a shorter period. Recently, strategies without PEX have been carried out in Jehovah's Witnesses with iTTP [5]. Impressively, improvement was rapid and comparable to those provided with a standard PEX-based treatment. Additionally, a treatment combining caplacizumab and immunosuppression only was successfully performed in six iTTP patients with severe neurologic and/or cardiac involvement. The rapid and durable improvement provides evidence that a regimen without plasma seems feasible. However, it's considered that robust data are still lacking to completely remove plasmatherapy from iTTP management. Based on these statements, the objective is to address the efficacy and safety of a PEX-free regimen, combining PI only (15 ml/kg/day), corticosteroids/rituximab, and caplacizumab.
Detailed description
Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe, autoantibody-mediated deficiency of ADAMTS13 leading to an accumulation of ultra-large von Willebrand factor multimers in plasma and finally to microthrombi in blood vessels. The current standard of care of iTTP consists in the triple association of daily plasma exchange (PEX, 60 ml/kg/day), immunosuppressive agents and anti-adhesive treatment (Caplacizumab). Our group recently reported the outcome of 90 patients with iTTP treated with this triple association and when compared to historical patients, the triplet regimen prevented death, refractoriness and exacerbations. Likewise, plasma volumes were reduced by 2 to 3-fold and the median number of PEX sessions could be reduced from 13 to 6. PEX is an invasive and time-consuming procedure, associated with catheter and plasma-related complications ranging from 22% to 30%. Consequently, to alleviate the burden of care in iTTP, using a regimen without PEX would represent a major and topical goal. Attempts to treat patients with plasma infusion (PI) without PEX were previously reported and provided evidence that large volumes of PI (20-30 ml/kg/day) improved the initial outcome of iTTP. However, fluid overload occurred in most cases after 5-7 days, limiting the feasibility of this strategy. Nevertheless, the recent availability of caplacizumab opens the perspective of treating patients with plasma for a shorter period. Recently, strategies without PEX have been carried out in Jehovah's Witnesses with iTTP [5]. Impressively, improvement was rapid and comparable to those provided with a standard PEX-based treatment. Additionally, a treatment combining caplacizumab and immunosuppression only was successfully performed in six iTTP patients with severe neurologic and/or cardiac involvement. The rapid and durable improvement provides evidence that a regimen without plasma seems feasible. However, it's considered that robust data are still lacking to completely remove plasmatherapy from iTTP management. Based on these statements, the objective is to address the efficacy and safety of a PEX-free regimen, combining PI only (15 ml/kg/day), corticosteroids/rituximab, and caplacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This trial is prospective, non-comparative, non-inferiority, single-arm, multicentric, national.
| Arm | Type | Receives |
|---|---|---|
| PEX-FREE | Experimental | Procedure: PEX-FREEReplacing daily PEX with daily plasma infusions (ie. Quarantine fresh frozen plasma (PFC-Se), solvent detergent/viral inactivated plasma (PFC-SD = OCTAPLASLG) or amotosalen-inactivated plasma (PFC-IA); volume 15mL/kg/day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEX-FREEAlso: PEX-FREE procedureThe study/experimental procedure consists in replacing daily PEX with daily plasma infusions (ie. Quarantine fresh frozen plasma (PFC-Se), solvent detergent/viral inactivated plasma (PFC-SD = OCTAPLASLG) or amotosalen-inactivated plasma (PFC-IA); volume 15mL/kg/day). | Procedure or surgery | PEX-FREE |
Primary outcome
To evaluate the efficacy of a PEX-FREE regimen in adults with iTTP as assessed by the proportion of participants day-30 post-plasma therapy death, refractoriness, exacerbation or an ADAMTS13 activity < 20%.
Time frame: 30 days
Complete plasma infusion treatment and clinical remission at day 30 defined by both lack of occurrence of any of the four events during the 30 days post plasma infusion procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEX-FREE in people with Thrombotic Microangiopathies, run by University Hospital, Rouen at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France, Reunion, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ygal Benhamou, Pr (02 32 88 90 03, ygal.benhamou@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of a PEX-FREE regimen in adults with iTTP as assessed by the proportion of participants day-30 post-plasma therapy death, refractoriness, exacerbation or an ADAMTS13 activity < 20%. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.