| 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 | | |
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 | 2 | US | Cemdisiran, ALN-CC5, Eculizumab, Soliris, Pozelimab, REGN3918, Ravulizumab, ALXN1210, Ultomiris | Regeneron Pharmaceuticals | Paroxysmal Nocturnal Hemoglobinuria | 07/23 | 07/23 | | |
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 | | |
Soliris, NCT05886244: Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China |
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| Active, not recruiting | 3 | 15 | RoW | Eculizumab | Alexion Pharmaceuticals, Inc., AstraZeneca | Paroxysmal Nocturnal Hemoglobinuria | 06/25 | 06/25 | | |
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 | 03/27 | 03/27 | | |
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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| Recruiting | 3 | 190 | Europe, Canada, Japan, US, RoW | Crovalimab, Eculizumab | Hoffmann-La Roche, Chugai Pharmaceutical | Paroxysmal Nocturnal Hemoglobinuria | 09/29 | 09/29 | | |
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 | | |
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 | | | | |
ChiCTR2300067949: The real world study of Eculizumab for paroxysmal nocturnal hemoglobinuria treatment in China |
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| Not yet recruiting | N/A | 10 | | Eculizumab | West China Hospitai, Sichuan University; West China Hospitai, Sichuan University, Apply for hospital project funds | paroxysmal nocturnal hemoglobinuria | | | | |
