CLINICAL TRIALS PROFILE FOR ECULIZUMAB
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Biosimilar Clinical Trials for eculizumab
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT04058158 ↗ | A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria | Completed | Samsung Bioepis Co., Ltd. | Phase 3 | 2019-08-07 | This is a randomised Phase III, double-blind, multicentre, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and Soliris® in subjects with PNH. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for eculizumab
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00098280 ↗ | Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 | 2004-12-01 | This study will examine the safety and effectiveness of the experimental drug eculizumab in treating patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare disorder of red blood cells that leads to premature destruction of the cells and resulting anemia. Patients may be at high risk of blood clots and may develop bone marrow failure or aplastic anemia, with low white blood cell and platelet counts. Eculizumab is a monoclonal antibody that may help improve the survival of red blood cells. Patients 18 years of age and older with PNH who require blood transfusions for anemia and have received at least four transfusions in the 12 months preceding evaluation for this study may be eligible to enroll. Candidates are screened with a medical history, physical examination, and check of vital signs. Participants have an electrocardiogram (EKG) and blood and urine tests, and are vaccinated against Neisseria meningitides, a common bacteria that can cause a disabling or fatal type of meningitis. They then enter an observation phase of the study, with monthly visits during which they complete a questionnaire; update their health status, transfusion record, and medication use; have their vital signs checked and PNH symptoms evaluated; have blood and urine tests; and receive a transfusion, if necessary. These visits continue for up to 3 months until patients receive a "qualifying" transfusion; that is, a transfusion given as a consequence of a certain hemoglobin level with symptoms or a different level without symptoms. Patients are then randomly assigned to receive either eculizumab or a placebo (salt solution with no active ingredient). Both study medications are given intravenously (through a vein) over 30 minutes once a week for five doses and then once every 2 weeks for another 11 doses. At each treatment visit (study weeks 0-24), patients update their health status, transfusion records, and medication use; have their vital signs checked; and provide a blood sample. At various visits, they also complete a questionnaire, provide a urine sample and have an EKG. At the last treatment visit (week 26 or the final visit for patients who end their participation before visit 18) patients have a complete physical examination in addition to the procedures listed above. |
| NCT00122304 ↗ | Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab | Completed | Alexion Pharmaceuticals | Phase 3 | 2004-12-01 | The primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic PNH |
| NCT00122317 ↗ | Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) | Completed | Alexion Pharmaceuticals | Phase 3 | 2005-05-01 | The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH. |
| NCT00122330 ↗ | Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients | Completed | Alexion Pharmaceuticals | Phase 3 | 2004-10-01 | The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH. |
| NCT00130000 ↗ | Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 | 2005-08-09 | This study will evaluate the safety and effectiveness of the experimental drug eculizumab for treating paroxysmal nocturnal hemoglobinuria (PNH), a disorder that can cause premature destruction of red blood cells. PNH may result in anemia requiring blood transfusions. Patients may be at high risk of life-threatening blood clots in their veins and may have urine discoloration, stomach pain, difficulty swallowing, tiredness, and poor quality of life. Men may have problems getting or maintaining an erection. Eculizumab is a monoclonal antibody that may improve the survival of red blood cells in patients with PNH. Patients 18 years of age and older who have been diagnosed with PNH for more than 6 months, who have active disease, and who require blood transfusions may be eligible for this study. Each candidate is screened with a physical examination, electrocardiogram, blood and urine tests, and a questionnaire for information on how PNH affects the patient physically, socially, emotionally, and functionally. Participants receive infusions of eculizumab through a needle in a vein once a week for five doses and then every two weeks for another 24 doses. All patients are vaccinated against Neisseria meningitides, a bacteria that can cause symptoms, possibly including life-threatening meningitis, in susceptible people, including people who take eculizumab. At every treatment visit, patients update their health status, transfusion record, and medication use; review their laboratory results from the preceding visit; have vital signs measured; and provide a blood sample for laboratory tests. At selected visits, they also provide a urine sample, have a repeat electrocardiogram, and complete a questionnaire. At the final treatment visit, participants have a complete physical examination, in addition to the routine procedures. |
| NCT00438789 ↗ | The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol | Approved for marketing | Alexion Pharmaceuticals | 1969-12-31 | The primary objective is to provide access to eculizumab for PNH patient pending commercial availability. | |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for eculizumab
Condition Name
| Condition Name for eculizumab | |
| Intervention | Trials |
| Paroxysmal Nocturnal Hemoglobinuria | 16 |
| Atypical Hemolytic Uremic Syndrome | 8 |
| Paroxysmal Nocturnal Hemoglobinuria (PNH) | 7 |
| Hemoglobinuria, Paroxysmal | 5 |
| [disabled in preview] | 0 |
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Clinical Trial Locations for eculizumab
Trials by Country
Clinical Trial Progress for eculizumab
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Clinical Trial Sponsors for eculizumab
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