Clinical trials: Eculizumab
Atypical Hemolytic-Uremic Syndrome
An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome
The record Primary purpose is to assess the efficacy of eculizumab in adult patients with Atypical Hemolytic- Uremic Syndrome (aHUS) to control Thrombotic Microangiopathy (TMA) as characterized by thrombocytopenia, hemolysis and…
- Trial name
- NCT01194973
- Testing
- Eculizumab
- Where
- 23 sites in United States, Belgium and 5 more
- Volunteers
- 44 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
NMOSD
Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD
Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare autoimmune condition that mainly affects the eyes and spinal cord, causing serious symptoms such as vision loss, paralysis, and severe pain.
- Trial name
- BEST-NMOSD (NCT07010302)
- Testing
- Rituximab (R), Eculizumab (Soliris®), Ravulizumab
- Where
- 3 sites in United States, Germany
- Volunteers
- 540 people
- Sponsor
- Massachusetts General Hospital
Antibody Mediated Rejection
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization…
- Trial name
- NCT01399593
- Testing
- Eculizumab
- Where
- 41 sites in United States, Australia and 8 more
- Volunteers
- 102 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Generalized Myasthenia Gravis (gMG), Refractory gMG
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG
This is an open-label, single-arm, multi-center study to evaluate the efficacy, safety, PK, PD, and immunogenicity of eculizumab in Chinese participants with refractory gMG.
- Trial name
- ECU-MG-304 (NCT06764160)
- Testing
- Eculizumab
- Where
- 6 sites in China
- Volunteers
- 15 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
Pozelimab and Cemdisiran Combination Therapy in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Switch From Eculizumab Therapy
The primary objective of the study is to evaluate the safety and tolerability of pozelimab and cemdisiran combination therapy in participants with PNH who switch from eculizumab therapy The secondary objectives of the study are…
- Trial name
- NCT04888507
- Testing
- Pozelimab, Cemdisiran
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Regeneron Pharmaceuticals
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.
- Trial name
- NCT02003144
- Testing
- eculizumab
- Where
- 69 sites in United States, Argentina and 18 more
- Volunteers
- 119 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
NMOSD
Efficacy and Safety of Monoclonal Antibody in Acute Phase of Neuromyelitis Optica Spectrum Disorder
This study aims to evaluate the efficacy and safety of different monoclonal antibody in the acute phase of neuromyelitis optica spectrum disorder (MAAP-NMO).
- Trial name
- NCT07182409
- Volunteers
- 40 people
- Sponsor
- First Affiliated Hospital of Chongqing Medical University
Paroxysmal Nocturnal Hemoglobinuria
Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria
The primary objective of the study is: To evaluate the effect of pozelimab and cemdisiran combination therapy on hemolysis, as assessed by lactate dehydrogenase (LDH), after 36 weeks of treatment, in patients with PNH who switch…
- Trial name
- ACCESS 2 (NCT05131204)
- Testing
- Cemdisiran, Eculizumab, Pozelimab
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Regeneron Pharmaceuticals
Neuromyelitis Optica Spectrum Disorder Attack
Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study
This project is a multi-center, prospective, real-world cohort study that collects clinical data of Chinese patients with AQP4-positive NMOSD in the acute stage.
- Trial name
- ETA/PETA-NMOSD (NCT07410039)
- Testing
- Eculizumab+IVMP, IVIG+IVMP, IVMP
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Chinese PLA General Hospital
Paroxysmal Nocturnal Hemoglobinuria
A Safety and Immunogenicity Study in Long-term Treatment of Eculizumab (JSC "GENERIUM", Russian Federation)
A safety and immunogenicity study in long-term treatment of Eculizumab (JSC "GENERIUM", Russian Federation) in patients with paroxysmal nocturnal hemoglobinuria, who have been involved earlier in the clinical trials of Eculizumab…
- Trial name
- NAP (NCT04679103)
- Testing
- Eculizumab (JSC GENERIUM, Russia)
- Where
- 9 sites in Russia
- Volunteers
- 50 people
- Sponsor
- AO GENERIUM
ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)
To Characterize the Safety and Tolerability of Eculizumab in Two Japanese aHUS Patients
This protocol is intended to formally collect data on the treatment of aHUS with eculizumab in Japanese patients.
- Trial name
- NCT01755429
- Where
- 2 sites in Japan
- Volunteers
- 2 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Transplant-Associated Thrombotic Microangiopathy (TA-TMA)
Safety and Efficacy of Eculizumab in High-risk TA-TMA
High-risk, complement-mediated, untreated transplant-associated thrombotic microangiopathy (hrTA-TMA) carries a very poor prognosis due to multiple organ dysfunction syndrome (MODS).
- Trial name
- NCT07707687
- Testing
- Eculizumab
- Where
- 8 sites in China
- Volunteers
- 24 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Neuromyelitis Optica, Devic's Disease
An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica
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 name
- NCT00904826
- Testing
- Eculizumab
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Mayo Clinic
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Targeting Complement Activation in Antineutrophil Cytoplasmic Autoantibodies (ANCA)-Vasculitis - Eculizumab
The purpose of this research study is to see if Eculizumab (Soliris®) can safely be used in addition to conventional therapy in patients with active ANCA (Antineutrophil Cytoplasmic Autoantibodies ) vasculitis and lead to a more…
- Trial name
- NCT01275287
- Testing
- Standard of care treatment, eculizumab
- Where
- United States
- Sponsor
- University of North Carolina, Chapel Hill
Paroxysmal Hemoglobinuria, Nocturnal
Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria
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.
- Trial name
- NCT00130000
- Testing
- Eculizumab
- Where
- United States
- Volunteers
- 87 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Paroxysmal Nocturnal Hemoglobinuria (PNH)
An Extension Clinical Study of BCD-148 for the Treatment of Patients With PNH Previously Treated in Clinical Study No. BCD-148-2/NOCTURN
To study the long-term safety and efficacy of BCD-148 in patients with paroxysmal nocturnal hemoglobinuria (PNH), previously treated in clinical study (CS) BCD-148-2/NOCTURN
- Trial name
- NCT06987864
- Testing
- eculizumab
- Where
- 11 sites in Russia
- Volunteers
- 24 people
- Sponsor
- Biocad
Paroxysmal Nocturnal Hemoglobinuria
Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
A study to assess the safety and efficacy of eculizumab in Japanese patients with hemolytic PNH.
- Trial name
- NCT01192399
- Testing
- Eculizumab
- Volunteers
- 29 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
CD55 - Cluster of Differentiation Antigen 55 Deficiency, Primary Intestinal Lymphangiectasis
Transcriptome and Metabolic Analyses of CHAPLE Disease
CHAPLE syndrome (complement hyperactivation, angiopathic thrombosis, protein losing enteropathy) is a newly discovered genetic disorder, which is caused by deleterious mutations in the CD55 gene.
- Conditions
- CD55 - Cluster of Differentiation Antigen 55 Deficiency, Primary Intestinal Lymphangiectasis, Protein-Losing Enteropathies, Complement Regulatory Factor Defect
- Trial name
- CHAPLEOMIC (NCT03950804)
- Testing
- Eculizumab Injection
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Marmara University
Kidney Transplant
Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Crossmatch Deceased Donor Kidney Transplant
The purpose of this study is to test whether a dosing regimen of eculizumab in addition to standard posttransplant care in positive crossmatch deceased donor kidney transplant recipients will reduce the incidence of acute humoral…
- Trial name
- NCT01106027
- Testing
- Eculizumab
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Mayo Clinic
Antibody-mediated Rejection, Humoral Rejection
Efficacy and Safety of Eculizumab for Treatment of Antibody-mediated Rejection Following Renal Transplantation
This is an open-label analysis that will compare eculizumab versus Plasmapheresis (PP) and Immunoglobulin (IVIg) for the treatment of antibody-mediated rejection (AMR) in renal transplant recipients.
- Trial name
- NCT01895127
- Testing
- Eculizumab, Immunoglobulin, Plasmapheresis
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Brigham and Women's Hospital