| Soliris (eculizumab) / AstraZeneca |
NCT00112983: Eculizumab in Treating Patients With Paroxysmal Nocturnal Hemoglobinuria |
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| Completed | 3 | | US | eculizumab | Jonsson Comprehensive Cancer Center | Leukemia | | 06/05 | | |
NCT00122330: Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients |
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| Completed | 3 | 75 | US, Canada, Europe, RoW | eculizumab | Alexion Pharmaceuticals | Hemoglobinuria, Paroxysmal | | 01/06 | | |
NCT00098280: Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria |
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| Completed | 3 | 75 | US | Eculizumab | National Heart, Lung, and Blood Institute (NHLBI) | Hemoglobinuria, Paroxysmal | | 02/06 | | |
| Completed | 3 | 85 | US, Canada, Europe, RoW | eculizumab | Alexion Pharmaceuticals | Hemoglobinuria, Paroxysmal | | 11/06 | | |
NCT00130000: Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria |
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| Completed | 3 | 87 | US | Eculizumab | National Heart, Lung, and Blood Institute (NHLBI) | Paroxysmal Hemoglobinuria, Nocturnal | | 06/07 | | |
| Completed | 3 | 187 | US, Canada, Europe, RoW | eculizumab, Soliris | Alexion Pharmaceuticals | Paroxysmal Hemoglobinuria, Nocturnal | 09/08 | 10/08 | | |
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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NCT04463056: Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH |
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| Completed | 3 | 32 | RoW | Elizaria®, eculizumab, Soliris® | AO GENERIUM | Paroxysmal Nocturnal Hemoglobinuria, Marchiafava-Micheli Syndrome, Paroxysmal Hemoglobinuria | 10/18 | 10/18 | | |
| Completed | 3 | 80 | Europe, Canada, Japan, US, RoW | Pegcetacoplan, APL-2, Soliris | Apellis Pharmaceuticals, Inc. | Paroxysmal Nocturnal Hemoglobinuria | 11/19 | 08/20 | | |
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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 | | |
NAP, NCT04679103: A Safety and Immunogenicity Study in Long-term Treatment of Eculizumab (JSC "GENERIUM", Russian Federation) |
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| Completed | 3 | 50 | RoW | Eculizumab (JSC GENERIUM, Russia) | AO GENERIUM | Paroxysmal Nocturnal Hemoglobinuria | 04/20 | 04/20 | | |
NCT04060264: Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria |
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| Completed | 3 | 28 | RoW | BCD-148, Soliris | Biocad | Paroxysmal Nocturnal Hemoglobinuria | 04/20 | 12/20 | | |
| Completed | 3 | 50 | Europe, RoW | SB12 (proposed eculizumab biosimilar), Soliris (eculizumab) | Samsung Bioepis Co., Ltd., Samsung Bioepis Co., Ltd. | Paroxysmal Nocturnal Hemoglobinuria | 09/21 | 10/21 | | |
NCT03056040 / 2016-002026-36: ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab |
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| Completed | 3 | 202 | Europe, Canada, Japan, US, RoW | Ravulizumab, ALXN1210, ULTOMIRIS, Eculizumab | Alexion Pharmaceuticals, Inc. | Paroxysmal Nocturnal Hemoglobinuria (PNH) | 04/22 | 04/22 | | |
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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 | 42 | Europe, US, RoW | ABP 959, Treatment T, Eculizumab, Soliris, Treatment R | Amgen | Paroxysmal Nocturnal Hemoglobinuria | 07/22 | 07/22 | | |
| 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 | | |
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 | | |
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 | | |
