CLINICAL TRIALS PROFILE FOR SOLIRIS
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Biosimilar Clinical Trials for SOLIRIS
| 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 SOLIRIS
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| 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. |
| NCT00670774 ↗ | Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant | Completed | Alexion Pharmaceuticals | Phase 1/Phase 2 | 2008-03-01 | A strongly positive crossmatch has long been considered an absolute contraindication to kidney transplantation and most patients with anti-human leukocyte antigen (HLA) antibody never were able to receive a kidney transplant. Over the past decade, significant progress has been made in overcoming early antibody-mediated renal allograft injury. Our group has performed more than 200 such transplants providing the possibility of transplant to previously untransplantable patients. Despite our best efforts, transplantation in these patients is still complicated by a high rate of acute humoral rejection (AHR). Patients included in this study will be those who have demonstrable anti-HLA antibody specific for their living donor. It is our hypothesis that blockade of terminal complement activation at the time of transplant in combination with our current protocols will reduce the incidence of AHR in patients with anti-donor HLA antibody. |
| NCT00670774 ↗ | Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant | Completed | Mark Stegall | Phase 1/Phase 2 | 2008-03-01 | A strongly positive crossmatch has long been considered an absolute contraindication to kidney transplantation and most patients with anti-human leukocyte antigen (HLA) antibody never were able to receive a kidney transplant. Over the past decade, significant progress has been made in overcoming early antibody-mediated renal allograft injury. Our group has performed more than 200 such transplants providing the possibility of transplant to previously untransplantable patients. Despite our best efforts, transplantation in these patients is still complicated by a high rate of acute humoral rejection (AHR). Patients included in this study will be those who have demonstrable anti-HLA antibody specific for their living donor. It is our hypothesis that blockade of terminal complement activation at the time of transplant in combination with our current protocols will reduce the incidence of AHR in patients with anti-donor HLA antibody. |
| NCT00727194 ↗ | Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis | Terminated | Alexion Pharmaceuticals | Phase 2 | 2008-10-01 | The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available. |
| NCT00867932 ↗ | Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH) | Completed | Alexion Pharmaceuticals | Phase 4 | 2009-10-02 | The primary objective of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) parameter estimates of eculizumab to confirm the dose regimens for pediatric and adolescent participants with PNH. |
| NCT00904826 ↗ | An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica | Completed | Alexion Pharmaceuticals | Phase 1/Phase 2 | 2009-04-01 | The purpose of this study is to determine if the drug eculizumab reduces the attack rate and improves outcome in patients with neuromyelitis optica. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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