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Clinical trials for Antiphospholipid syndrome

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    15 result(s) found for: Antiphospholipid syndrome. Displaying page 1 of 1.
    EudraCT Number: 2013-003588-73 Sponsor Protocol Number: ALXN1007-APS-201 Start Date*: 2014-07-28
    Sponsor Name:Alexion Pharmaceuticals Inc.
    Full Title: AN OPEN-LABEL PROOF OF CONCEPT PHASE IIA TRIAL OF ALXN1007 FOR THE TREATMENT OF NON-CRITERIA MANIFESTATIONS OF ANTIPHOSPHOLIPID SYNDROME
    Medical condition: Persistently aPL-positive patients with at least 1 of the following non-criteria manifestations: aPL-nephropathy, skin ulcers and/or thrombocytopenia.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10002817 Antiphospholipid syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-004568-25 Sponsor Protocol Number: BLAST Start Date*: 2021-08-18
    Sponsor Name:DIPARTIMENTO DI SCIENZE CLINICHE E BIOLOGICHE (UNITO)
    Full Title: Open-label, prospective, phase II descriptive pilot trial of belimumab therapy for refractory and/or non-criteria manifestations of Antiphospholipid Syndrome.
    Medical condition: APS
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10002817 Antiphospholipid syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-004866-86 Sponsor Protocol Number: P160944J Start Date*: 2020-01-23
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Evaluation of the benefit of adjuvant treatment with hydroxychloroquine to usual medical care for uncomplicated term pregnancy in patients with primary obstetrical antiphospholipid syndrome: random...
    Medical condition: Primary obstetrical antiphospholipid syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10002817 Antiphospholipid syndrome PT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002182-38 Sponsor Protocol Number: 2015/074/HP Start Date*: 2015-09-28
    Sponsor Name:CHU - Hôpitaux de Rouen
    Full Title: Study of the Plaquenil® efficacy on the endothelial dysfunction and its vascular consequences during the antiphospholipid syndrom
    Medical condition: Patients must meet the classification criteria for arterial antiphospholipids syndrom. They must have had a confirmed episode of arterial thrombosis and the presence of 2 tests performed at 12 week...
    Disease: Version SOC Term Classification Code Term Level
    18.0 10005329 - Blood and lymphatic system disorders 10002817 Antiphospholipid syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-002345-38 Sponsor Protocol Number: 12/0033/CTU/IMM/001 Start Date*: 2012-10-30
    Sponsor Name:University College London
    Full Title: A prospective randomised controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE.
    Medical condition: Patients with antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE).
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021428 - Immune system disorders 10002817 Antiphospholipid syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-019764-36 Sponsor Protocol Number: SAP-02 Start Date*: 2011-02-03
    Sponsor Name:JOSEP ORDI-ROS
    Full Title: RIVAROXABAN VERSUS ACENOCUMAROL EN LA PROFILAXIS SECUNDARIA DEL SÍNDROME ANTIFOSFOLÍPIDO:UN ESTUDIO MULTICÉNTRICO, PROSPECTIVO Y RANDOMIZADO.
    Medical condition: Sindrome Antifosfolípido
    Disease: Version SOC Term Classification Code Term Level
    13 10002817 Síndrome antifosfolípido LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-002478-11 Sponsor Protocol Number: 2.0 Start Date*: 2016-07-19
    Sponsor Name:Medical University of Vienna, Department of Internal medicine I
    Full Title: Very low doses of Rituximab for off-label treatment – a Pilot Trial
    Medical condition: Autoimmune-haemolytic Anemia Antiphospholipid Syndrome Immune-mediated Thrombocytopenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000154058 10003825 Autoimmune hemolytic anemia LLT
    20.0 100000157088 10023095 ITP LLT
    20.0 10005329 - Blood and lymphatic system disorders 10002817 Antiphospholipid syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001177-78 Sponsor Protocol Number: APHP191008 Start Date*: 2021-02-25
    Sponsor Name:University of Utah
    Full Title: Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with APS or SLE
    Medical condition: Pregnant women with Antiphospholipid Syndrom (APS) and Lupus Antocoagulant (LAC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10002817 Antiphospholipid syndrome PT
    20.1 100000004848 10058347 Lupus anticoagulant positive LLT
    20.0 100000004848 10058355 Lupus anticoagulant LLT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-001377-28 Sponsor Protocol Number: 27577 Start Date*: 2008-06-11
    Sponsor Name:Merck Serono International S.A.
    Full Title: Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of...
    Medical condition: Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosp...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061664 Autoimmune disorder LLT
    9.1 10025139 Lupus erythematosus systemic LLT
    9.1 10047888 Wegener's granulomatosis LLT
    9.1 10002817 Antiphospholipid syndrome LLT
    9.1 10040767 Sjogren's syndrome LLT
    9.1 10039073 Rheumatoid arthritis LLT
    9.1 10028245 Multiple sclerosis LLT
    9.1 10045228 Type I diabetes mellitus LLT
    9.1 10011401 Crohn's disease LLT
    9.1 10009900 Colitis ulcerative LLT
    9.1 10003827 Autoimmune hepatitis LLT
    9.1 10049046 Autoimmune thyroiditis LLT
    9.1 10003822 Autoimmune haemolytic anaemia NOS LLT
    9.1 10034697 Pernicious anemia LLT
    9.1 10028417 Myasthenia gravis LLT
    9.1 10018620 Goodpasture's syndrome LLT
    9.1 10018766 Guillain Barre syndrome LLT
    9.1 10043554 Thrombocytopenia LLT
    9.1 10037153 Psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Prematurely Ended) AT (Prematurely Ended) NL (Prematurely Ended) PT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001735-49 Sponsor Protocol Number: CTU/2015/174 Start Date*: 2019-07-01
    Sponsor Name:University College London
    Full Title: Rivaroxaban versus warfarin for stroke patients with antiphospholipid syndrome, with or without SLE (RISAPS): a randomised, controlled, open-label, phase II/III, non-inferiority trial
    Medical condition: Patients with stroke or other ischaemic brain injury who have antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10002817 Antiphospholipid syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-004575-13 Sponsor Protocol Number: TRAPS-1.5 Start Date*: 2014-10-29
    Sponsor Name:Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova
    Full Title: A prospective, randomized clinical trial comparing Rivaroxaban vs warfarin in high risk patients with antiphospholipid syndrome (TRAPS).
    Medical condition: THROMBOEMBOLISM PREVENTION
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-006651-39 Sponsor Protocol Number: 111103 Start Date*: 2008-12-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IV, randomized, open-label, controlled, post-licensure study to evaluate the safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix®) when administered intramuscular...
    Medical condition: No medical condition will be investigated in this study. The study will follow vaccinated females and collect safety data focussing on autoimmune diseases, pregnancy outcomes and SAEs considered to...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-006954-17 Sponsor Protocol Number: C08-003A Start Date*: 2009-06-18
    Sponsor Name:ALEXION PHARMACEUTICALS, INC.
    Full Title: AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)
    Medical condition: Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018932 Haemolytic uraemic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) SE (Completed) AT (Completed) FR (Completed) ES (Prematurely Ended) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-006955-28 Sponsor Protocol Number: C08-003B Start Date*: 2009-08-19
    Sponsor Name:ALEXION PHARMACEUTICALS, INC.
    Full Title: AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)
    Medical condition: Adolescent patients (from 12 and up to 18 years of age weighing ≥ 40 kg) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018932 Haemolytic uraemic syndrome LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) SE (Completed) AT (Completed) ES (Prematurely Ended) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-000257-83 Sponsor Protocol Number: VT-001-0070 Start Date*: 2022-11-22
    Sponsor Name:Vera Therapeutics, Inc.
    Full Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with Active Lupus Nephritis
    Medical condition: patients with lupus nephritis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10025140 Lupus nephritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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