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
-

Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

First Posted Date
2012-12-27
Last Posted Date
2018-08-31
Lead Sponsor
Russian Academy of Medical Sciences
Target Recruit Count
57
Registration Number
NCT01756508
Locations
🇷🇺

Russian Scientfic Center of Surgery, Moscow, Russian Federation

An Open Label Study of the Effects of Eculizumab in CD59 Deficiency

Phase 1
Conditions
Interventions
First Posted Date
2012-04-18
Last Posted Date
2012-04-18
Lead Sponsor
Hadassah Medical Organization
Target Recruit Count
5
Registration Number
NCT01579838
Locations
🇮🇱

Hadassah Medical Center, Jerusalem, Israel

Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-03-30
Last Posted Date
2019-05-03
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
80
Registration Number
NCT01567085

A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant

First Posted Date
2011-07-27
Last Posted Date
2019-05-06
Lead Sponsor
Schroppel, Bernd, M.D.
Target Recruit Count
8
Registration Number
NCT01403389
Locations
🇺🇸

Mount Sinai Recanati/Miller Transplantation Institute, New York, New York, United States

Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2011-07-22
Last Posted Date
2017-10-03
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
102
Registration Number
NCT01399593

Eculizumab Therapy for Chronic Complement-Mediated Injury in Kidney Transplantation

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-04-01
Last Posted Date
2019-08-12
Lead Sponsor
Sanjay Kulkarni
Target Recruit Count
16
Registration Number
NCT01327573
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

Therapy of Chronic Cold Agglutinin Disease With Eculizumab

Phase 2
Completed
Conditions
Interventions
First Posted Date
2011-02-25
Last Posted Date
2017-07-19
Lead Sponsor
University Hospital, Essen
Target Recruit Count
13
Registration Number
NCT01303952
Locations
🇩🇪

Department of Hematology, University Hospital Essen, Essen, Germany

Targeting Complement Activation in Antineutrophil Cytoplasmic Autoantibodies (ANCA)-Vasculitis - Eculizumab

First Posted Date
2011-01-12
Last Posted Date
2017-02-23
Lead Sponsor
University of North Carolina, Chapel Hill
Registration Number
NCT01275287
Locations
🇺🇸

UNC Kidney Center, Chapel Hill, North Carolina, United States

Eculizumab Therapy for Dense Deposit Disease and C3 Nephropathy

First Posted Date
2010-10-14
Last Posted Date
2019-02-19
Lead Sponsor
Columbia University
Target Recruit Count
6
Registration Number
NCT01221181
Locations
🇺🇸

Columbia University Medical Center, Nephrology Clinical Research Center, New York, New York, United States

🇺🇸

Columbia University Medical Center, Glomerular Center, New York, New York, United States

E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-09-03
Last Posted Date
2019-09-17
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
27
Registration Number
NCT01194804
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