Clinical trials: Eculizumab
Neuromyelitis Optica Spectrum Disorder Attack
Eculizumab For Acute Attack of Neuromyelitis Optica Spectrum Disorder
Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing, inflammatory autoimmune disorder of the central nervous system characterized by the pathogenic anti-aquaporin 4 antibody (AQP4-IgG).
- Trial name
- EASE-NMO (NCT06673394)
- Testing
- Complement protein C5 inhibitor, IVMP
- Sponsor
- Tianjin Medical University General Hospital
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.
End Stage Liver Disease
Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation
The number of liver transplants that can be performed is limited by the availability of organs. Livers that are steatotic (i.e., infiltrated by triglycerides and other fatty substances) are usually not used for transplants, due…
- Trial name
- NCT03468140
- Testing
- Eculizumab, No intervention
- Where
- United States
- Sponsor
- Yale University
Atypical Hemolytic Uremic Syndrome
Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUS
The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).
- Trial name
- aHUS (NCT00844545)
- Testing
- Eculizumab
- Where
- 17 sites in United States, Austria and 3 more
- Volunteers
- 16 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab
The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to eculizumab.
- Trial name
- NCT03030183
- Testing
- Zilucoplan (RA101495)
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- Ra Pharmaceuticals
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder
The objective of this study is to evaluate the safety and efficacy of eculizumab in pediatric participants (aged 2 to < 18 years) with relapsing neuromyelitis optica spectrum disorder (NMOSD).
- Trial name
- NCT04155424
- Testing
- Eculizumab
- Where
- 35 sites in United States, Canada and 5 more
- Volunteers
- 5 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.
Paroxysmal Nocturnal Hemoglobinuria
Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry
This study is a collection of data to evaluate safety and characterize progression of Paroxysmal Nocturnal Hemoglobinuria (PNH).
- Trial name
- NCT01374360
- Where
- United States
- Volunteers
- 6,061 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Atypical Hemolytic Uremic Syndrome (aHUS)
A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
The objective of this retrospective trial is to assess safety and efficacy of eculizumab in aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.
- Trial name
- NCT01770951
- Where
- 23 sites in United States, Austria and 6 more
- Volunteers
- 30 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria, PNH
Danicopan Early Access Program
This is an EAP, designed to provide early access to danicopan for participants with PNH experiencing clinically significant EVH who have failed, not tolerated, or are unable to receive other approved treatments; in the Treating…
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria, PNH, Extravascular Hemolysis
- Trial name
- NCT05982938
- Testing
- Danicopan
- Where
- 15 sites in Italy
- Sponsor
- Alexion Pharmaceuticals, Inc.
Myasthenia Gravis, Myasthenia Gravis, Juvenile Form
A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of eculizumab in the treatment of pediatric refractory gMG based on change from Baseline in the Quantitative Myasthenia Gravis…
- Conditions
- Myasthenia Gravis, Myasthenia Gravis, Juvenile Form, Myasthenia Gravis, Generalized
- Trial name
- NCT03759366
- Testing
- Eculizumab
- Where
- 11 sites in United States, Japan
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Subclinical Acute Antibody-mediated Rejection in Kidney Transplantation
Eculizumab Therapy for Subclinical Antibody-mediated Rejection in Kidney Transplantation
Advances in renal transplantation have increased life-expectancy in patients with end-stage kidney disease. Conventional immunosuppressive drugs prevent efficiently early allograft losses due to T-cell mediated rejection.
- Trial name
- TAMARCIN (NCT02113891)
- Testing
- Eculizumab
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Thrombocytopenia, Alloimmune Platelet Refractoriness
Complement Inhibition Using Eculizumab to Overcome Platelet Transfusion Refractoriness in Patients With Severe Thrombocytopenia
Background: Platelets are tiny cells in the blood that help stop bleeding. Thrombocytopenia happens when people do not have enough normal platelets.
- Trial name
- NCT02298933
- Testing
- Eculizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Paroxysmal Nocturnal Hemoglobinuria
Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
This is a Phase 3b, single-arm, open-label, multicenter study to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of eculizumab in adult participants with paraxysmal noturnal…
- Trial name
- Soliris (NCT05886244)
- Testing
- Eculizumab
- Where
- 7 sites in China
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Neuromyelitis Optica Spectrum Disorders (NMOSD)
Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder
Study Title: A National, Multicenter, Randomized Controlled Trial of the Modified Zipper Therapy in AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (ELITE Study) Brief Summary: The goal of this clinical trial is to…
- Trial name
- ELITE (NCT07420296)
- Testing
- Eculizumab administration, High-dose corticosteroid pulse therapy, Plasma exchange (PE)
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Tianjin Medical University General Hospital
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
HELLP Syndrome (HELLP), Third Trimester, Complement Abnormality
The Use of Eculizumab in HELLP Syndrome
This research study is being performed to see if women diagnosed with early preterm Hemolysis, Elevated Liver Enzymes, Low Platelets (HELLP) syndrome (estimated gestational ages of 23-30 weeks) benefit from a medication called…
- Conditions
- HELLP Syndrome (HELLP), Third Trimester, Complement Abnormality, Morbidity;Newborn, Maternal Injury
- Trial name
- NCT04103489
- Testing
- Eculizumab
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Johns Hopkins University
Paroxysmal Nocturnal Hemoglobinuria (PNH)
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants With Inadequate Response to C5 Inhibitor Therapy
The purpose of this study was to determine the efficacy and safety of BCX9930 monotherapy for the treatment of PNH compared to continued C5 inhibitor therapy in adult PNH participants with residual anemia despite treatment with a…
- Trial name
- REDEEM-1 (NCT05116774)
- Testing
- Eculizumab, Ravulizumab, BCX9930
- Where
- 7 sites in France, Hungary and 3 more
- Volunteers
- 12 people
- Sponsor
- BioCryst Pharmaceuticals
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.
Antiphospholipid Antibody Syndrome, End Stage Renal Disease
Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome
Catastrophic Antiphospholipid Antibody Syndrome (CAPS) is a rare condition in which life-threatening blood clots form in multiple organs simultaneously and can lead to multi-organ system failure and death.
- Trial name
- NCT01029587
- Testing
- Eculizumab
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Johns Hopkins University