Clinical trials: Eculizumab
Covid19
COVID-19 Soliris Expanded Access Protocol
This protocol provides participants with COVID-19 access to Soliris.
- Trial name
- NCT04802083
- Testing
- Eculizumab
- Sponsor
- Alexion Pharmaceuticals, Inc.
COVID-19, Pneumonia, Viral
SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19
This protocol provides access to eculizumab treatment for participants with severe COVID-19.
- Conditions
- COVID-19, Pneumonia, Viral, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
- Trial name
- NCT04355494
- Testing
- eculizumab
- Where
- 12 sites in United States, France
- Sponsor
- Alexion Pharmaceuticals, Inc.
Observational
Real-World Treatment Study of Soliris (Eculizumab)
As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients who are treated with Soliris in normal clinical practice settings.
- Trial name
- SolirisPMS (NCT06448715)
- Where
- 2 sites in South Korea
- Volunteers
- 11 people
- Sponsor
- AstraZeneca
Paroxysmal Nocturnal Hemoglobinuria
Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris
This is a Phase II, open-label study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 in PNH patients undergoing complement-inhibitor therapy with Soliris.
- Trial name
- NCT05646563
- Testing
- NM8074, Soliris
- Volunteers
- 12 people
- Sponsor
- NovelMed Therapeutics
Paroxysmal Nocturnal Haemoglobinuria (PNH)
Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH)
Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.
- Trial name
- NCT02591862
- Testing
- Coversin
- Where
- Netherlands
- Volunteers
- 1 people
- Sponsor
- AKARI Therapeutics
Refractory Generalized Myasthenia Gravis
Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis
To evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study ECU-MG-301(NCT01997229).
- Trial name
- NCT02301624
- Testing
- Eculizumab
- Where
- 60 sites in United States, Argentina and 15 more
- Volunteers
- 117 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Myasthenia Gravis
Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis
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…
- Trial name
- NCT00727194
- Testing
- eculizumab
- Where
- 25 sites in United States, Canada and 1 more
- Volunteers
- 14 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
NMOSD, Neuromyelitis Optica Spectrum Disorders
Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD
The primary objective of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Eculizumab in Chinese Adults with Neuromyelitis Optica Spectrum Disorders (NMOSD).
- Trial name
- ECU-NMO-304 (NCT06724809)
- Testing
- eculizumab
- Where
- 7 sites in China
- Volunteers
- 21 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
Stage V Chronic Kidney Disease
Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
Primary Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
- Trial name
- NCT01567085
- Testing
- Eculizumab
- Where
- 15 sites in Australia, France and 4 more
- Volunteers
- 80 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously administered ravulizumab in adult participants…
- Trial name
- NCT03748823
- Testing
- Ravulizumab OBDS, Ravulizumab
- Where
- 51 sites in United States, Australia and 12 more
- Volunteers
- 139 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy Subjects
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Healthy Volunteers
- Trial name
- NCT04027803
- Testing
- BCD-148, Soliris
- Where
- Russia
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Biocad
Paroxysmal Hemoglobinuria, Nocturnal
Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)
The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.
- Trial name
- NCT00122317
- Testing
- eculizumab
- Where
- 40 sites in United States, Australia and 10 more
- Volunteers
- 187 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)
The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.
- Trial name
- NCT04469465
- Testing
- Danicopan, C5 Inhibitor
- Where
- 62 sites in United States, Brazil and 16 more
- Volunteers
- 86 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
PNH
A Retrospective Non-Interventional Study to Evaluate the Impact of Eculizumab in Korean PNH Patients
This study is a retrospective non-interventional study, and the main objective of this study is to identify the impact of eculizumab treatment and the improvement of complications before and after eculizumab treatment, and to…
- Trial name
- NCT05337683
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- Handok Inc.
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.
Atypical Hemolytic-Uremic Syndrome
An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome
The primary purpose is to assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.
- Trial name
- aHUS (NCT01193348)
- Testing
- Eculizumab
- Where
- 17 sites in United States, Australia and 7 more
- Volunteers
- 22 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
A Study of the Efficacy and Safety of FXS6837 Capsules Compared to Eculizumab for 24 Weeks in Patients With PNH.
An open label study to evaluate the efficacy and safety of FXS6837 capsules compared to eculizumab in naive PNH patients. About 90 PNH patients who are naive to complement inhibitor therapies will be enrolled to take FXS6837…
- Trial name
- NCT07747090
- Testing
- FXS6837 Capsule, Eculizumab infusion
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
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.
Shiga-like Toxin-producing Escherichia Coli
Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
This protocol is designed to collect safety and efficacy data on patients that have been or will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in Germany.
- Trial name
- STEC-HUS (NCT01410916)
- Testing
- Eculizumab (Soliris®)
- Where
- 22 sites in Germany
- Volunteers
- 198 people
- Sponsor
- Alexion Pharmaceuticals, Inc.