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: -

Clinical Trials

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

Phase 2

Completed

Conditions: Atypical Hemolytic Uremic Syndrome

Interventions: Drug: eculizumab

First Posted Date: 2009-02-16

Last Posted Date: 2015-07-23

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 5

Registration Number: NCT00844428

Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (aHUS)

Phase 2

Completed

Conditions: Atypical Hemolytic Uremic Syndrome

Interventions: Drug: eculizumab

First Posted Date: 2009-02-06

Last Posted Date: 2015-07-23

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 15

Registration Number: NCT00838513

Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis

Phase 2

Terminated

Conditions: Myasthenia Gravis

Interventions: Drug: eculizumab
Drug: Placebo

First Posted Date: 2008-08-01

Last Posted Date: 2019-09-24

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 14

Registration Number: NCT00727194

Locations: 🇺🇸
University of California, Irvine, Orange, California, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

and more 22 locations

Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant

Phase 1

Completed

Conditions: Kidney Transplant

Interventions: Drug: Eculizumab

First Posted Date: 2008-05-02

Last Posted Date: 2018-06-26

Lead Sponsor: Mark Stegall

Target Recruit Count: 31

Registration Number: NCT00670774

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Safety and Efficacy Study of Eculizumab in Patients With Mild Allergic Asthma

Phase 2

Completed

Conditions: Allergic Asthma

First Posted Date: 2007-06-13

Last Posted Date: 2009-01-15

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 21

Registration Number: NCT00485576

Locations: 🇨🇦
Hospital Laval, Ste-Foy, Quebec, Canada
🇨🇦
McMaster University, Hamilton, Ontario, Canada

The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

Conditions: Hemoglobinuria, Paroxysmal

First Posted Date: 2007-02-22

Last Posted Date: 2014-05-06

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Registration Number: NCT00438789

Locations: 🇺🇸
Anthony Botti, Livingston, New Jersey, United States

Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria

Phase 3

Completed

Conditions: Paroxysmal Hemoglobinuria, Nocturnal

First Posted Date: 2005-08-12

Last Posted Date: 2017-07-02

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 87

Registration Number: NCT00130000

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

Phase 3

Completed

Conditions: Hemoglobinuria, Paroxysmal

First Posted Date: 2005-07-22

Last Posted Date: 2006-12-04

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 75

Registration Number: NCT00122330

Locations: 🇺🇸
University of California at Los Angeles, Los Angeles, California, United States
🇺🇸
Washington University School of Medicine, Dept. of Internal Medicine/Division of Hematology, St. Louis, Missouri, United States
🇺🇸
Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program, Philadelphia, Pennsylvania, United States

and more 40 locations

Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)

Phase 3

Completed

Conditions: Paroxysmal Hemoglobinuria, Nocturnal

Interventions: Drug: eculizumab

First Posted Date: 2005-07-22

Last Posted Date: 2018-03-13

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 187

Registration Number: NCT00122317

Locations: 🇺🇸
Hartford Hospital, Cancer Clinical Research Office, Hartford, Connecticut, United States
🇺🇸
Cleveland Clinic Foundation, Cleveland, Ohio, United States
🇦🇺
The Royal Perth Hospital, Department of Haematology/Level 2, Perth, Western Australia, Australia

and more 37 locations

Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab

Phase 3

Completed

Conditions: Hemoglobinuria, Paroxysmal

First Posted Date: 2005-07-22

Last Posted Date: 2007-02-21

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 85

Registration Number: NCT00122304

Locations: 🇺🇸
NYU Clinical Cancer Center, New York, New York, United States
🇺🇸
Johns Hopkins University Medical Center, Baltimore, Maryland, United States
🇺🇸
Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program, Philadelphia, Pennsylvania, United States

and more 45 locations

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