Clinical trials: Eculizumab
ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)
To Characterize the Safety and Tolerability of Eculizumab in Two Japanese aHUS Patients
This protocol is intended to formally collect data on the treatment of aHUS with eculizumab in Japanese patients.
- Trial name
- NCT01755429
- Where
- 2 sites in Japan
- Volunteers
- 2 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
Generalized Myasthenia Gravis
Registry of Participants With Generalized Myasthenia Gravis Treated With Alexion C5 Inhibition Therapies (C5ITs)
Long-term, multicenter, multinational, observational, registry of patients with gMG that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT) such as eculizumab…
- Trial name
- NCT04202341
- Where
- 51 sites in United States, Austria and 5 more
- Volunteers
- 500 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).
- Trial name
- NCT02946463
- Testing
- Ravulizumab, Eculizumab
- Where
- 120 sites in United States, Argentina and 24 more
- Volunteers
- 272 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria
This clinical study is a randomized, open-label, international, multi-center, comparative study of efficacy and safety of BCD-148 and Soliris® in PNH patients.
- Trial name
- NCT04060264
- Testing
- BCD-148, Soliris
- Where
- Russia
- Volunteers
- 28 people
- Sponsor
- Biocad
Paroxysmal Nocturnal Hemoglobinuria, Marchiafava-Micheli Syndrome
Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH
It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Elizaria® (eculizumab, GENERIUM JSC, Russia) versus Soliris® (Alexion Pharma GmbH, Switzerland) in patients with paroxysmal nocturnal…
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria, Marchiafava-Micheli Syndrome, Paroxysmal Hemoglobinuria
- Trial name
- NCT04463056
- Testing
- Elizaria®, Soliris®
- Where
- 4 sites in Russia
- Volunteers
- 32 people
- Sponsor
- AO GENERIUM
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.
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.
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.
Hemoglobinuria, Paroxysmal
Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab
The primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic PNH
- Trial name
- NCT00122304
- Testing
- eculizumab
- Where
- 48 sites in United States, Australia and 11 more
- Volunteers
- 85 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors
A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy.
- Trial name
- COMMODORE 2 (NCT04434092)
- Testing
- Crovalimab, Eculizumab
- Where
- 63 sites in Argentina, Brazil and 21 more
- Volunteers
- 210 people
- Sponsor
- Hoffmann-La Roche
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.