Eculizumab

Generic Name
Eculizumab
Brand Names
Soliris, Epysqli, Bekemv
Drug Type
Biotech
Chemical Formula
-
CAS Number
219685-50-4
Unique Ingredient Identifier
A3ULP0F556
Background

Eculizumab is a monoclonal antibody that targets complement protein C5. Binding to this protein prevents the activation of a complement terminal complex, which is used to treat a number of autoimmune conditions.
...

Indication

Eculizumab is indicated in the US to treat paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy, and neuromyelitis optica spectrum disorder (NMOSD). It is also indicated in EU to treat PNH in both adult and pediatric patients.

Associated Conditions
Generalized Myasthenia Gravis, Neuromyelitis Optica Spectrum Disorders, Paroxysmal Nocturnal Haemoglobinuria (PNH), Thrombotic Microangiopathies
Associated Therapies
-

An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-09-03
Last Posted Date
2017-05-30
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
44
Registration Number
NCT01194973

An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-09-01
Last Posted Date
2015-04-29
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
22
Registration Number
NCT01193348

Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Crossmatch Deceased Donor Kidney Transplant

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2010-04-19
Last Posted Date
2018-01-31
Lead Sponsor
Mayo Clinic
Target Recruit Count
2
Registration Number
NCT01106027
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Eculizumab to Prevent Antibody-mediated Rejection in ABO Blood Group Incompatible Living Donor Kidney Transplantation

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2010-03-30
Last Posted Date
2015-07-20
Lead Sponsor
Mayo Clinic
Target Recruit Count
6
Registration Number
NCT01095887
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome

First Posted Date
2009-12-10
Last Posted Date
2020-10-26
Lead Sponsor
Johns Hopkins University
Target Recruit Count
1
Registration Number
NCT01029587
Locations
🇺🇸

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)

First Posted Date
2009-07-09
Last Posted Date
2017-05-30
Lead Sponsor
Philip J. Rosenfeld, MD, PhD
Target Recruit Count
60
Registration Number
NCT00935883
Locations
🇺🇸

Bascom Palmer Eye Institute, Miami, Florida, United States

An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-05-20
Last Posted Date
2013-11-03
Lead Sponsor
Mayo Clinic
Target Recruit Count
14
Registration Number
NCT00904826
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH)

Phase 4
Completed
Conditions
Interventions
First Posted Date
2009-03-24
Last Posted Date
2018-10-31
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
7
Registration Number
NCT00867932

Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUS

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-02-16
Last Posted Date
2015-07-23
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
16
Registration Number
NCT00844545

Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant aHUS

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-02-16
Last Posted Date
2015-07-23
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
1
Registration Number
NCT00844844
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