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Clinical trials for Eculizumab

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • 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   44346   clinical trials with a EudraCT protocol, of which   7374   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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    69 result(s) found for: Eculizumab. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2013-003589-15 Sponsor Protocol Number: ECU-MG-301 Start Date*: 2014-02-03
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)
    Medical condition: Generalized Myasthenia Gravis
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004859 10071942 Myasthenia gravis and related conditions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) IT (Completed) GB (Completed) DE (Completed) ES (Completed) BE (Completed) NL (Completed) DK (Completed) GR (Completed) FI (Completed) HU (Completed) CZ (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-000597-26 Sponsor Protocol Number: BO42161 Start Date*: Information not available in EudraCT
    Sponsor Name:F.Hoffmann-La Roche Ltd
    Full Title: A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PA...
    Medical condition: PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) BE (Trial now transitioned) GR (Trial now transitioned) HU (Completed) CZ (Trial now transitioned) PT (Trial now transitioned) IE (Trial now transitioned) NL (Trial now transitioned) EE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003916-37 Sponsor Protocol Number: 08448 Start Date*: 2018-04-13
    Sponsor Name:Newcastle Upon Tyne Hospitals NHS Foundation Trust
    Full Title: Multicentre, open label, prospective, single arm study of the safety and impact of eculizumab withdrawal in patients with atypical haemolytic uraemic syndrome
    Medical condition: Atypical Haemolytic Uraemic Syndrome (aHUS)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2013-003826-10 Sponsor Protocol Number: EAGLE Start Date*: 2014-01-24
    Sponsor Name:IRCCS- Mario Negri Institute
    Full Title: EVALUATING THE MORPHOFUNCTIONAL EFFECTS OF ECULIZUMAB THERAPY IN PRIMARY MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS: A PILOT, SINGLE ARM STUDY IN TEN PATIENTS WITH PERSISTENT HEAVY PROTEINURIA
    Medical condition: Membranoproliferative glomerulonephritis
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-002191-41 Sponsor Protocol Number: ECU-MG-302 Start Date*: 2014-10-27
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)
    Medical condition: Generalized Myasthenia Gravis
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004859 10071942 Myasthenia gravis and related conditions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) BE (Completed) DE (Completed) SE (Completed) HU (Completed) ES (Completed) NL (Completed) DK (Completed) CZ (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2019-004931-21 Sponsor Protocol Number: BO42162 Start Date*: 2020-10-26
    Sponsor Name:F. Hoffman-La Roche Ltd.
    Full Title: A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTUR...
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) DE (Trial now transitioned) HU (Completed) FR (Trial now transitioned) PL (Trial now transitioned) GR (Completed) PT (Trial now transitioned) BE (Completed) IE (Prematurely Ended) NL (Trial now transitioned) EE (Completed) LT (Trial now transitioned) IT (Prematurely Ended) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-002329-84 Sponsor Protocol Number: APHP211039 Start Date*: 2023-01-06
    Sponsor Name:ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)
    Full Title: Eculizumab in hypertensive emergency-associated hemolytic uremic syndrome: a randomized multicenter controlled trial.
    Medical condition: Adult patients with aHUS associated with HE and severe kidney involvement (needing dialysis or serum creatinine ≥ 354µM).
    Disease: Version SOC Term Classification Code Term Level
    20.1 10005329 - Blood and lymphatic system disorders 10079840 Atypical haemolytic uraemic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001418-27 Sponsor Protocol Number: 20150168 Start Date*: 2019-01-29
    Sponsor Name:Amgen Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) NL (Completed) GB (GB - no longer in EU/EEA) CZ (Completed) NO (Completed) SI (Completed) IE (Completed) FI (Completed) SE (Completed) PT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-001453-10 Sponsor Protocol Number: BA41510 Start Date*: 2019-09-16
    Sponsor Name:Roche Farma S. A. U. que realiza el ensayo en España y que actua como representante F.Hoffmann-La Roche Ltd
    Full Title: A MULTICENTER, LOW-INTERVENTIONAL STUDY DOCUMENTING THE EFFICACY, HEALTH-RELATED QUALITY OF LIFE, AND SAFETY OF STANDARD-OF-CARE TREATMENT WITH ECULIZUMAB OR TREATMENT WITH RAVULIZUMAB IN PATIENTS ...
    Medical condition: Paroxysmal nocturnal hemoglobinuria (PNH) that is treated with either eculizumab or ravulizumab as per local label
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-019631-35 Sponsor Protocol Number: C10-002 Start Date*: 2012-05-02
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: AN OPEN-LABEL, SINGLE-ARM, MULTICENTER TRIAL TO DETERMINE SAFETY AND EFFICACY OF ECULIZUMAB IN THE PREVENTION OF ANTIBODY MEDIATED REJECTION (AMR) IN SENSITIZED RECIPIENTS OF A KIDNEY TRANSPLANT FR...
    Medical condition: Antibody mediated rejection after kidney transplant
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004870 10064683 Antibody-mediated rejection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) IT (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003440-74 Sponsor Protocol Number: ALXN1210-PNH-401 Start Date*: 2020-05-14
    Sponsor Name:Alexion Pharmaceuticals Inc.
    Full Title: Phase 4, Single-Arm Study of Ravulizumab in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with High-Dose Eculizumab
    Medical condition: Paroxysmal nocturnal hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2020-003565-19 Sponsor Protocol Number: DR200088 Start Date*: 2021-04-26
    Sponsor Name:CHRU DE TOURS
    Full Title: Espacement personnalisé des perfusions d’eculizumab basé sur un suivi thérapeutique pharmacologique : évaluation médicoéconomique prospective multicentrique chez les patients en rémission atteints ...
    Medical condition: Patients en rémission atteints d’un syndrome hémolytique et urémique atypique nécessitant un traitement au long cours par eculizumab
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001151-12 Sponsor Protocol Number: ECU-NMO-302 Start Date*: 2013-12-12
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)
    Medical condition: Neuromyelitis Optica
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10029322 Neuromyelitis optica LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) GB (GB - no longer in EU/EEA) ES (Completed) AT (Completed) CZ (Completed) DK (Completed) FR (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2013-001150-10 Sponsor Protocol Number: ECU-NMO-301 Start Date*: 2013-12-12
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)
    Medical condition: Neuromyelitis Optica
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004852 10029322 Neuromyelitis optica LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) IT (Completed) GB (Prematurely Ended) ES (Completed) AT (Prematurely Ended) CZ (Prematurely Ended) DK (Prematurely Ended) FR (Completed) HR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003168-22 Sponsor Protocol Number: 2020/0206/HP Start Date*: 2021-09-02
    Sponsor Name:Rouen University Hospital
    Full Title: Multicenter, uncontrolled pilot study evaluating the efficacy of eculizumab in the treatment of gemcitabine-induced thrombotic microangiopathies.
    Medical condition: Thrombotic microangiopathies induced by gemcitabine
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-004650-25 Sponsor Protocol Number: ECU-DGF-201 Start Date*: 2014-08-12
    Sponsor Name:Alexion Pharmaceuticals Incorporated
    Full Title: A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multi-Center Study of Eculizumab for the Prevention of Delayed Graft Function after Kidney Transplantation in Adult Subjects at Incre...
    Medical condition: Delayed Graft Function
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004863 10048747 Renal graft function delayed LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Completed) CZ (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-002437-15 Sponsor Protocol Number: BO42354 Start Date*: 2021-09-23
    Sponsor Name:Roche Farma S. A. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, OPEN-LABEL, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB IN ADOLESCENT AND PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS)
    Medical condition: Atypical Hemolytic Uremic Syndrome (aHUS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004851 10079841 Atypical hemolytic uremic syndrome LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) BE (Trial now transitioned) PL (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001619-21 Sponsor Protocol Number: OPTIMAB Start Date*: 2019-10-07
    Sponsor Name:HOSPITAL UNIVERSITARI DE BELLVITGE- IDIBELL
    Full Title: PILOT STUDY FOR THE OPTIMITZATION OF THE MAINTENANCE DOSE OF ECULIZUMAB ACCORDING TO THE WEIGHT IN ADULT PATIENTS WITH ATYPIC HEMOLYTIC UREMIC SYNDROME
    Medical condition: ATYPICAL HEMOLYTIC UREMIC SYNDROME
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004851 10079841 Atypical hemolytic uremic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-019630-28 Sponsor Protocol Number: C10-001 Start Date*: 2011-10-19
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL TO DETERMINE SAFETY AND EFFICACY OF ECULIZUMAB IN THE PREVENTION OF ANTIBODY MEDIATED REJECTION (AMR) IN LIVING DONOR KIDNEY TRANSPLANT RECIPIENTS REQUIR...
    Medical condition: Antibody mediated rejection after kidney transplant
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004870 10064683 Antibody-mediated rejection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) NO (Prematurely Ended) NL (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended) SE (Completed)
    Trial results: View results
    EudraCT Number: 2005-000043-28 Sponsor Protocol Number: E05-001 Start Date*: 2005-04-19
    Sponsor Name:ALEXION PHARMACEUTICALS INCORPORATED
    Full Title: A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SH...
    Medical condition: paroxysmal nocturnal hemoglobinuria
    Disease: Version SOC Term Classification Code Term Level
    7.0 10034042 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) SE (Completed) DE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
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