| Soliris (eculizumab) / AstraZeneca |
2019-001453-10: A 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 with Paroxysmal Nocturnal Hemoglobinuria Un estudio de baja intervención que documenta la eficacia, la calidad de vida relacionada con la salud y la seguridad del tratamiento se referencia con eculizumab o el tratamiento con ravulizumab en pacientes con hemoglobinuria nocturna paroxística |
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| Ongoing | 4 | 200 | Europe | ECULIZUMAB, Ultomiris, Concentrate for solution for infusion, Soliris 300, ULTOMIRIS | Roche Farma S. A. U. que realiza el ensayo en España y que actua como representante F.Hoffmann-La Roche Ltd, F. Hoffman-La Roche Ltd., Chugai Pharmaceutical Co. Ltd | Paroxysmal nocturnal hemoglobinuria (PNH) that is treated with either eculizumab or ravulizumab as per local label Hemoglobinuria paroxística nocturna (HPN) que se trata con eculizumab o ravulizumab según la etiqueta local, PNH is a rare, acquired life-threatening disease, characterized by presence of impaired red blood cells that are easily destroyed, leading to hemoglobin in the urine and anemia as main manifestations HPN es enfermedad rara, adqui q pone en peligro la vida, por la presencia de glóbu rojos deteriorados q se destruyen fácil, lo q lleva a la hemoglobina en orina y anemia como manifestaciones ppales, Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
2019-003440-74: Phase 4, Single-Arm Study of Ravulizumab in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with High-Dose Eculizumab |
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| Not yet recruiting | 4 | 20 | Europe | ULTOMIRIS, ALXN1210, Concentrate for solution for infusion, ULTOMIRIS | Alexion Pharmaceuticals Inc., Alexion Pharmaceuticals, Inc. | Paroxysmal nocturnal hemoglobinuria (PNH), Paroxysmal nocturnal hemoglobinuria (PNH), Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
NCT02946463 / 2016-002025-11: ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) |
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| Completed | 3 | 272 | Europe, Canada, Japan, US, RoW | Ravulizumab, Eculizumab | Alexion Pharmaceuticals, Inc. | Paroxysmal Nocturnal Hemoglobinuria (PNH) | 02/23 | 02/23 | | |
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NCT03748823 / 2017-002370-39: Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab |
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| Completed | 3 | 139 | Europe, Canada, US, RoW | Ravulizumab OBDS, Ravulizumab, ALXN1210 | Alexion Pharmaceuticals, Inc. | Paroxysmal Nocturnal Hemoglobinuria | 02/21 | 08/23 | | |
NCT03759366 / 2016-001384-37: A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG) |
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| Completed | 3 | 11 | Europe, Japan, US | Eculizumab | Alexion Pharmaceuticals, Inc. | Myasthenia Gravis, Myasthenia Gravis, Juvenile Form, Myasthenia Gravis, Generalized | 01/22 | 11/23 | | |
ALPHA, NCT04469465 / 2019-003829-18: Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH) |
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| Completed | 3 | 86 | Europe, Canada, Japan, US, RoW | Danicopan, ALXN2040, Placebo, C5 Inhibitor | Alexion Pharmaceuticals, Inc. | Paroxysmal Nocturnal Hemoglobinuria | 06/22 | 01/24 | | |
| Completed | 3 | 97 | Europe, Japan, US, RoW | LNP023, iptacopan, Eculizumab, Ravulizumab | Novartis Pharmaceuticals | Paroxysmal Nocturnal Hemoglobinuria (PNH) | 09/22 | 03/23 | | |
COMMODORE 2, NCT04434092 / 2019-004931-21: A Phase III Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors. |
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| Active, not recruiting | 3 | 204 | Europe, Japan, RoW | Crovalimab, Eculizumab | Hoffmann-La Roche, Chugai Pharmaceutical | Paroxysmal Nocturnal Hemoglobinuria | 11/22 | 06/28 | | |
ACCESS 2, NCT05131204 / 2020-002761-33: Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria |
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| Terminated | 3 | 3 | US | Cemdisiran, ALN-CC5, Eculizumab, Soliris, Pozelimab, REGN3918, Ravulizumab, ALXN1210, Ultomiris | Regeneron Pharmaceuticals | Paroxysmal Nocturnal Hemoglobinuria | 07/23 | 07/23 | | |
ConfIdeS, NCT04935177: Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx |
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| Active, not recruiting | 3 | 64 | US | Imlifidase, IdeS, HMED-IdeS, PLEX, Plasma exchange, PE, IVIg, Intravenous immunoglobulin, Anti-CD20 antibodies, Rituximab, Eculizumab, Soliris, Remain on wait list | Hansa Biopharma AB | Kidney Transplantation in Highly Sensitized Patients | 06/25 | 06/25 | | |
NCT06449001: Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis |
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| Not yet recruiting | 3 | 6 | NA | Danicopan | Alexion Pharmaceuticals, Inc. | Paroxysmal Nocturnal Hemoglobinuria, PNH, Extravascular Hemolysis | 01/27 | 01/28 | | |
HRS-5965-301, NCT06593938: A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy |
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| Not yet recruiting | 3 | 70 | RoW | HRS-5965 capsule, Eculizumab Injection | Chengdu Suncadia Medicine Co., Ltd. | Paroxysmal Nocturnal Hemoglobinuria | 12/25 | 12/25 | | |
Soliris, NCT05886244: Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China |
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| Active, not recruiting | 3 | 25 | RoW | Eculizumab | Alexion Pharmaceuticals, Inc., AstraZeneca | Paroxysmal Nocturnal Hemoglobinuria | 06/25 | 06/25 | | |
Soliris, NCT05876351: Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China |
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| Recruiting | 3 | 25 | RoW | Eculizumab | Alexion Pharmaceuticals, Inc., AstraZeneca | Atypical Hemolytic Uremic | 03/26 | 03/26 | | |
ACCESS-1, NCT05133531 / 2020-004486-40: A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment |
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| Recruiting | 3 | 190 | Europe, Canada, Japan, US, RoW | Ravulizumab, ALXN1210, Ultomiris, Pozelimab, REGN3918, Cemdisiran, ALN-CC5, Eculizumab, Soliris | Regeneron Pharmaceuticals | Paroxysmal Nocturnal Hemoglobinuria | 04/27 | 04/27 | | |
COMMODORE 1, NCT04432584 / 2020-000597-26: A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors |
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| Active, not recruiting | 3 | 190 | Europe, Canada, Japan, US, RoW | Crovalimab, Eculizumab | Hoffmann-La Roche, Chugai Pharmaceutical | Paroxysmal Nocturnal Hemoglobinuria | 09/29 | 09/29 | | |
2019-001829-26: A Trial to Evaluate the Safety and Activity of Eculizumab in PediatricPatients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD) Ensayo para evaluar la seguridad y actividad de eculizumab en pacientes pediátricos con trastorno del espectro de la neuromielitis óptica recidivante |
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| Not yet recruiting | 2/3 | 15 | Europe | Soliris, Soliris, Concentrate for solution for infusion, Soliris | Alexion Pharmaceuticals Inc., ALEXION PHARMACEUTICALS INCORPORATED, Alexion Pharmaceuticals Inc, Alexion Pharmaceuticals Inc. | Neuromyelitis Optica Spectrum Disorder (NMOSD) Trastorno del espectro de la neuromielitis óptica (TENMO), Neuromyelitis Optica Spectrum Disorder (NMOSD) Trastorno del espectro de la neuromielitis óptica (TENMO), Diseases [C] - Nervous System Diseases [C10] | | | | |
ECU-NMO-303, NCT04155424: A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder |
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| Terminated | 2/3 | 5 | Europe, Canada, Japan, US, RoW | Eculizumab, Soliris | Alexion Pharmaceuticals, Inc. | Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder | 07/23 | 07/23 | | |
2017-003916-37: Stopping Eculizumab Treatment Safely in atypical Haemolytic Uraemic Syndrome (SETS aHUS) |
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| Not yet recruiting | 2 | 50 | Europe | Solaris, Infusion, Solaris | Newcastle Upon Tyne Hospitals NHS Foundation Trust, National Institute for Health Research | Atypical Haemolytic Uraemic Syndrome (aHUS), aHUS is a rare disease caused by a fault in the complement system. The complement system is part of your body’s immune response that attacks bugs., Diseases [C] - Immune System Diseases [C20] | | | | |
2017-004307-51: Inflammation inhibitors to reduce brain injury after a hemorrhagic stroke. Ontstekingsremmers om schade na bloeding tussen hersenvliezen te verminderen. |
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| Ongoing | 2 | 40 | Europe | Powder for infusion, Soliris | University Medical Center Utrecht, ZonMW/Hersenstichting, Alexion Pharmaceuticals | Aneurysmal subarachnoid hemorrhage Aneurysmatische subarachnoïdale bloeding, Stroke Hersenvliesbloeding, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
2018-004382-13: Safety and efficacy of Cemdisiran in athypical hemolytic uremic syndrome Sicurezza ed efficacia di Cendisiran nella Sindrome emolitico-uremica atipica. |
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| Not yet recruiting | 2 | 12 | Europe | ALN-CC5, [ALN-62643], Solution for injection | IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI, Alnylam Pharmaceutical Inc. Cambridge, MA, Istituto di Ricerche Farmacologiche Mario negri | Atypical Hemolytic Uremic Syndrome Sindrome emolitico uremica atipica, Atypical Hemolytic Uremic Syndrome Sindrome emolitico uremica atipica, Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
2020-003168-22: Study evaluating the efficacy of eculizumab in the treatment of gemcitabine-induced thrombotic microangiopathies. Etude évaluant l’efficacité de l’eculizumab dans le traitement des microangiopathies thrombotiques induites par la gemcitabine |
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| Not yet recruiting | 2 | 10 | Europe | SOLIRIS®, EU/1/07/393/001, Solution for infusion, SOLIRIS® | Rouen University Hospital, Rouen University Hospital | Thrombotic microangiopathies induced by gemcitabine Microangiopathies thrombotiques induites par la gemcitabine, Thrombotic microangiopathies induced by gemcitabine Microangiopathies thrombotiques induites par la gemcitabine, Diseases [C] - Cancer [C04] | | | | |
NCT04888507: Pozelimab and Cemdisiran Combination Therapy in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Switch From Eculizumab Therapy |
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| Completed | 2 | 6 | Europe | Pozelimab, REGN3918, Cemdisiran, ALN-CC5 | Regeneron Pharmaceuticals | Paroxysmal Nocturnal Hemoglobinuria | 05/22 | 05/23 | | |
| Terminated | 2 | 12 | Europe | BCX9930, Eculizumab, Soliris, Ravulizumab, Ultomiris, ALXN1210, ravulizumab-cwvz | BioCryst Pharmaceuticals | Paroxysmal Nocturnal Hemoglobinuria (PNH) | 09/23 | 09/23 | | |
NCT05646563: Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris |
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| Not yet recruiting | 2 | 12 | NA | NM8074, Soliris, Eculizumab | NovelMed Therapeutics | Paroxysmal Nocturnal Hemoglobinuria | 08/26 | 01/27 | | |
NCT05731050: Study of NM8074 in Soliris-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) |
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| Not yet recruiting | 2 | 6 | NA | NM8074 | NovelMed Therapeutics | PNH - Paroxysmal Nocturnal Hemoglobinuria | 08/26 | 10/26 | | |
NCT05863442: Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants |
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| Recruiting | 1 | 120 | RoW | Soliris 300 MG in 30 ML Injection, TUR03 300 MG in 30 ML Injection | Turgut Ardika PTY LTD | Healthy | 07/24 | 10/24 | | |
NCT04355494: SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19 |
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| No Longer Available | N/A | | Europe, US | eculizumab, Soliris | Alexion Pharmaceuticals | COVID-19, Pneumonia, Viral, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) | | | | |
| No Longer Available | N/A | | NA | Eculizumab, Soliris, monoclonal antibody | Alexion Pharmaceuticals | Covid19 | | | | |
NAP, NCT04671810: Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria® |
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| Completed | N/A | 44 | RoW | Elizaria®, Eculizumab | AO GENERIUM | Paroxysmal Nocturnal Hemoglobinuria | 12/22 | 05/23 | | |
| Available | N/A | | NA | Danicopan, ALXN2040 | Alexion Pharmaceuticals, Inc. | Paroxysmal Nocturnal Hemoglobinuria, PNH, Extravascular Hemolysis | | | | |
| Recruiting | N/A | 11 | RoW | | AstraZeneca | Observational | 10/24 | 10/24 | | |