Soliris (eculizumab) / Handok, AstraZeneca 
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47 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Soliris (eculizumab) / AstraZeneca
2019-001453-10: A Low-Interventional Study Documenting the Efficacy, Health-Related Quality of Life, and Safety of Standard-Of-Care Treatment with Eculizumab or Treatment with Ravulizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria Un estudio de baja intervención que documenta la eficacia, la calidad de vida relacionada con la salud y la seguridad del tratamiento se referencia con eculizumab o el tratamiento con ravulizumab en pacientes con hemoglobinuria nocturna paroxística

Ongoing
4
200
Europe
ECULIZUMAB, Ultomiris, Concentrate for solution for infusion, Soliris 300, ULTOMIRIS
Roche Farma S. A. U. que realiza el ensayo en España y que actua como representante F.Hoffmann-La Roche Ltd, F. Hoffman-La Roche Ltd., Chugai Pharmaceutical Co. Ltd
Paroxysmal nocturnal hemoglobinuria (PNH) that is treated with either eculizumab or ravulizumab as per local label Hemoglobinuria paroxística nocturna (HPN) que se trata con eculizumab o ravulizumab según la etiqueta local, PNH is a rare, acquired life-threatening disease, characterized by presence of impaired red blood cells that are easily destroyed, leading to hemoglobin in the urine and anemia as main manifestations HPN es enfermedad rara, adqui q pone en peligro la vida, por la presencia de glóbu rojos deteriorados q se destruyen fácil, lo q lleva a la hemoglobina en orina y anemia como manifestaciones ppales, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2019-001619-21: OPTIMIZATION OF MAINTENANCE DOSE WITH ECULIZUMAB ACCORDING TO WEIGHT IN PATIENTS WITH ATYPIC HAEMOLITHIC URINE MUSCLE SYNDROME OPTIMIZACIÓN DE LA DOSIS DE MANTENIMIENTO CON ECULIZUMAB SEGÚN EL PESO EN PACIENTES CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO

Not yet recruiting
4
10
Europe
Solution for infusion, SOLIRIS
HOSPITAL UNIVERSITARI DE BELLVITGE- IDIBELL, HOSPITAL UNIVERSITARI DE BELLVITGE-IDIBELL
ATYPICAL HEMOLYTIC UREMIC SYNDROME SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO, ATYPICAL HEMOLYTIC UREMIC SYNDROME SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO, Not possible to specify
 
 
2019-003440-74: Phase 4, Single-Arm Study of Ravulizumab in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with High-Dose Eculizumab

Not yet recruiting
4
20
Europe
ULTOMIRIS, ALXN1210, Concentrate for solution for infusion, ULTOMIRIS
Alexion Pharmaceuticals Inc., Alexion Pharmaceuticals, Inc.
Paroxysmal nocturnal hemoglobinuria (PNH), Paroxysmal nocturnal hemoglobinuria (PNH), Diseases [C] - Blood and lymphatic diseases [C15]
 
 
NCT02946463 / 2016-002025-11: ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Checkmark In PNH
Apr 2018 - Apr 2018: In PNH
Completed
3
272
Europe, Canada, Japan, US, RoW
Ravulizumab, Eculizumab
Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
02/23
02/23
NCT03748823 / 2017-002370-39: Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

Completed
3
139
Europe, Canada, US, RoW
Ravulizumab OBDS, Ravulizumab, ALXN1210
Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
02/21
08/23
2020-003565-19: Espacement personnalisé des perfusions d’eculizumab basé sur un suivi thérapeutique pharmacologique : évaluation médicoéconomique prospective multicentrique chez les patients en rémission atteints d’un syndrome hémolytique et urémique atypique nécessitant un traitement au long cours. Espacement personnalisé des perfusions d’eculizumab basé sur un suivi thérapeutique pharmacologique : évaluation médicoéconomique prospective multicentrique chez les patients en rémission atteints d’un syndrome hémolytique et urémique atypique nécessitant un traitement au long cours.

Not yet recruiting
3
80
Europe
SOLIRIS, L04AA25, Solution for injection, SOLIRIS
CHRU DE TOURS, CHRU DE TOURS
Patients en rémission atteints d’un syndrome hémolytique et urémique atypique nécessitant un traitement au long cours par eculizumab Patients en rémission atteints d’un syndrome hémolytique et urémique atypique nécessitant un traitement au long cours par eculizumab, Patients en rémission atteints d’un syndrome hémolytique et urémique atypique nécessitant un traitement au long cours par eculizumab Patients en rémission atteints d’un syndrome hémolytique et urémique atypique nécessitant un traitement au long cours par eculizumab, Not possible to specify
 
 
NCT03759366 / 2016-001384-37: A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)

Completed
3
11
Europe, Japan, US
Eculizumab
Alexion Pharmaceuticals, Inc.
Myasthenia Gravis, Myasthenia Gravis, Juvenile Form, Myasthenia Gravis, Generalized
01/22
11/23
ALPHA, NCT04469465 / 2019-003829-18: Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)

Completed
3
86
Europe, Canada, Japan, US, RoW
Danicopan, ALXN2040, Placebo, C5 Inhibitor
Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
06/22
01/24
EspacECU, NCT04859608: Personalized Spacing of Eculizumab Infusions Based on Therapeutic Pharmacological Monitoring

Active, not recruiting
3
40
Europe
Spacing of Eculizumab infusions
University Hospital, Tours, Centre Hospitalier Universitaire, Amiens, University Hospital, Angers, Centre Hospitalier Universitaire de Besancon, University Hospital, Caen, Centre Hospitalier of Chartres, Nantes University Hospital, University of Nancy, Poitiers University Hospital, Rennes University Hospital, University Hospital, Rouen, University Hospital, Strasbourg, France, Centre Hospitalier Universitaire de Nice, Hôpital Necker-Enfants Malades, Tenon Hospital, Paris, University Hospital, Lille, Reims University Hospital, University Hospital, Clermont-Ferrand, Assistance Publique Hopitaux De Marseille, Hospices Civils de Lyon
Hemolytic-Uremic Syndrome, Atypical
12/23
06/24
APPLY-PNH, NCT04558918 / 2019-004665-40: Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment

Completed
3
97
Europe, Japan, US, RoW
LNP023, iptacopan, Eculizumab, Ravulizumab
Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria (PNH)
09/22
03/23
COMMODORE 2, NCT04434092 / 2019-004931-21: A Phase III Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.

Active, not recruiting
3
204
Europe, Japan, RoW
Crovalimab, Eculizumab
Hoffmann-La Roche, Chugai Pharmaceutical
Paroxysmal Nocturnal Hemoglobinuria
11/22
06/28
ACCESS 2, NCT05131204 / 2020-002761-33: Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria

Terminated
3
3
US
Cemdisiran, ALN-CC5, Eculizumab, Soliris, Pozelimab, REGN3918, Ravulizumab, ALXN1210, Ultomiris
Regeneron Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria
07/23
07/23
ConfIdeS, NCT04935177: Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx

Active, not recruiting
3
64
US
Imlifidase, IdeS, HMED-IdeS, PLEX, Plasma exchange, PE, IVIg, Intravenous immunoglobulin, Anti-CD20 antibodies, Rituximab, Eculizumab, Soliris, Remain on wait list
Hansa Biopharma AB
Kidney Transplantation in Highly Sensitized Patients
06/25
06/25
NCT06449001: Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis

Not yet recruiting
3
6
NA
Danicopan
Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria, PNH, Extravascular Hemolysis
01/27
01/28
HRS-5965-301, NCT06593938: A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy

Not yet recruiting
3
70
RoW
HRS-5965 capsule, Eculizumab Injection
Chengdu Suncadia Medicine Co., Ltd.
Paroxysmal Nocturnal Hemoglobinuria
12/25
12/25
Soliris, NCT05886244: Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China

Active, not recruiting
3
25
RoW
Eculizumab
Alexion Pharmaceuticals, Inc., AstraZeneca
Paroxysmal Nocturnal Hemoglobinuria
06/25
06/25
GEMECULI, NCT05702996: Multicenter, Uncontrolled Pilot Study Evaluating the Efficacy of Eculizumab in the Treatment of Gemcitabine-induced Thrombotic Microangiopathies

Not yet recruiting
3
10
Europe
Eculizumab administration
University Hospital, Rouen
Thrombotic Microangiopathies
09/25
09/25
Soliris, NCT05876351: Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China

Recruiting
3
25
RoW
Eculizumab
Alexion Pharmaceuticals, Inc., AstraZeneca
Atypical Hemolytic Uremic
03/26
03/26
HYPERSHU, NCT05726916: Eculizumab in Hypertensive Emergency-associated Hemolytic Uremic Syndrome

Recruiting
3
66
Europe
Soliris®, Eculizumab, Renin angiotensin system blockers
Assistance Publique - Hôpitaux de Paris
Hypertensive Emergency-associated Hemolytic Uremic Syndrome
05/26
11/27
ACCESS-1, NCT05133531 / 2020-004486-40: A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment

Recruiting
3
190
Europe, Canada, Japan, US, RoW
Ravulizumab, ALXN1210, Ultomiris, Pozelimab, REGN3918, Cemdisiran, ALN-CC5, Eculizumab, Soliris
Regeneron Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria
04/27
04/27
COMMODORE 1, NCT04432584 / 2020-000597-26: A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

Active, not recruiting
3
190
Europe, Canada, Japan, US, RoW
Crovalimab, Eculizumab
Hoffmann-La Roche, Chugai Pharmaceutical
Paroxysmal Nocturnal Hemoglobinuria
09/29
09/29
2019-001829-26: A Trial to Evaluate the Safety and Activity of Eculizumab in PediatricPatients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD) Ensayo para evaluar la seguridad y actividad de eculizumab en pacientes pediátricos con trastorno del espectro de la neuromielitis óptica recidivante

Not yet recruiting
2/3
15
Europe
Soliris, Soliris, Concentrate for solution for infusion, Soliris
Alexion Pharmaceuticals Inc., ALEXION PHARMACEUTICALS INCORPORATED, Alexion Pharmaceuticals Inc, Alexion Pharmaceuticals Inc.
Neuromyelitis Optica Spectrum Disorder (NMOSD) Trastorno del espectro de la neuromielitis óptica (TENMO), Neuromyelitis Optica Spectrum Disorder (NMOSD) Trastorno del espectro de la neuromielitis óptica (TENMO), Diseases [C] - Nervous System Diseases [C10]
 
 
ECU-NMO-303, NCT04155424: A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder

Terminated
2/3
5
Europe, Canada, Japan, US, RoW
Eculizumab, Soliris
Alexion Pharmaceuticals, Inc.
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
07/23
07/23
ACTRN12611000880943: Safety & Efficacy of Eculizumab to Prevent antibody mediated rejection in Living Donor Kidney Transplant Recipients Requiring Desensitization

Recruiting
2
80
 
Alexion Pharmaceuticals Australasia Pty Ltd, Alexion Pharmaceuticals Australasia Pty Ltd
Kidney transplant
 
 
ACTRN12611000461998: Study to evaluate if eculizumab is efficient and safe enough to be used for treatment of children with atypical hemolytic-uremic syndrome

Active, not recruiting
2
15
 
Alexion Pharmaceuticals Australasia Pty Ltd, Alexion Pharmaceuticals Australasia Pty Ltd
Atypical Hemolytic-Uremic Syndrome
 
 
ACTRN12612000333819: Safety and Efficacy of Eculizumab to prevent antibody mediated rejection in sensitized kidney transplant recipients from a deceased donor

Recruiting
2
40
 
Alexion Pharmaceuticals Inc, Alexion Pharmaceuticals Inc
kidney transplant
 
 
2017-003916-37: Stopping Eculizumab Treatment Safely in atypical Haemolytic Uraemic Syndrome (SETS aHUS)

Not yet recruiting
2
50
Europe
Solaris, Infusion, Solaris
Newcastle Upon Tyne Hospitals NHS Foundation Trust, National Institute for Health Research
Atypical Haemolytic Uraemic Syndrome (aHUS), aHUS is a rare disease caused by a fault in the complement system. The complement system is part of your body’s immune response that attacks bugs., Diseases [C] - Immune System Diseases [C20]
 
 
2017-004307-51: Inflammation inhibitors to reduce brain injury after a hemorrhagic stroke. Ontstekingsremmers om schade na bloeding tussen hersenvliezen te verminderen.

Ongoing
2
40
Europe
Powder for infusion, Soliris
University Medical Center Utrecht, ZonMW/Hersenstichting, Alexion Pharmaceuticals
Aneurysmal subarachnoid hemorrhage Aneurysmatische subarachnoïdale bloeding, Stroke Hersenvliesbloeding, Diseases [C] - Cardiovascular Diseases [C14]
 
 
2018-004382-13: Safety and efficacy of Cemdisiran in athypical hemolytic uremic syndrome Sicurezza ed efficacia di Cendisiran nella Sindrome emolitico-uremica atipica.

Not yet recruiting
2
12
Europe
ALN-CC5, [ALN-62643], Solution for injection
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI, Alnylam Pharmaceutical Inc. Cambridge, MA, Istituto di Ricerche Farmacologiche Mario negri
Atypical Hemolytic Uremic Syndrome Sindrome emolitico uremica atipica, Atypical Hemolytic Uremic Syndrome Sindrome emolitico uremica atipica, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2020-003168-22: Study evaluating the efficacy of eculizumab in the treatment of gemcitabine-induced thrombotic microangiopathies. Etude évaluant l’efficacité de l’eculizumab dans le traitement des microangiopathies thrombotiques induites par la gemcitabine

Not yet recruiting
2
10
Europe
SOLIRIS®, EU/1/07/393/001, Solution for infusion, SOLIRIS®
Rouen University Hospital, Rouen University Hospital
Thrombotic microangiopathies induced by gemcitabine Microangiopathies thrombotiques induites par la gemcitabine, Thrombotic microangiopathies induced by gemcitabine Microangiopathies thrombotiques induites par la gemcitabine, Diseases [C] - Cancer [C04]
 
 
NCT04888507: Pozelimab and Cemdisiran Combination Therapy in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Switch From Eculizumab Therapy

Completed
2
6
Europe
Pozelimab, REGN3918, Cemdisiran, ALN-CC5
Regeneron Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria
05/22
05/23
REDEEM-1, NCT05116774 / 2020-004438-39: BCX9930 for Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor Therapy

Terminated
2
12
Europe
BCX9930, Eculizumab, Soliris, Ravulizumab, Ultomiris, ALXN1210, ravulizumab-cwvz
BioCryst Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria (PNH)
09/23
09/23
NCT06513338: Complement C5 mAb in the Treatment of Anti-GBM Disease

Recruiting
2
8
RoW
Eculizumab
Peking University First Hospital
Autoimmune Diseases
08/26
12/26
ChiCTR2400084781: A Study on the Efficacy and Safety of Sequential Efgartigimod and Telitacicept Therapy in the Treatment of Generalized Myasthenia Gravis

Not yet recruiting
2
30
 
The patients in the treatment group received a dose of 10mg/kg of eculizumab via intravenous infusion over 1 hour once a week for 4 consecutive weeks in the first month. Starting from the second month, they began receiving a subcutaneous injection of 240mg of Telitacicept acetate weekly, and continued long-term Telitacicept acetate treatment until the end of the 24-week study observation period.
Peking University People's Hospital; Peking University People's Hospital, The research was funded by the National Natural Science Foundation of China (Grant No. 81303013).
myasthenia gravis
 
 
NCT05646563: Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris

Not yet recruiting
2
12
NA
NM8074, Soliris, Eculizumab
NovelMed Therapeutics
Paroxysmal Nocturnal Hemoglobinuria
08/26
01/27
NCT05731050: Study of NM8074 in Soliris-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Not yet recruiting
2
6
NA
NM8074
NovelMed Therapeutics
PNH - Paroxysmal Nocturnal Hemoglobinuria
08/26
10/26
NCT06453135: Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation

Not yet recruiting
1/2
30
RoW
Eculizumab, Soliris
Tao Lin
Kidney Transplantation
07/25
12/25
NCT04103489: The Use of Eculizumab in HELLP Syndrome

Completed
1
3
US
Eculizumab, Soliris
Johns Hopkins University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
HELLP Syndrome (HELLP), Third Trimester, Complement Abnormality, Morbidity;Newborn, Maternal Injury, Preeclampsia Severe
08/23
09/23
NCT05863442: Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants

Recruiting
1
120
RoW
Soliris 300 MG in 30 ML Injection, TUR03 300 MG in 30 ML Injection
Turgut Ardika PTY LTD
Healthy
07/24
10/24
SOLID-C19, NCT04288713: Eculizumab (Soliris) in Covid-19 Infected Patients

Available
N/A
NA
Eculizumab
Hudson Medical
Coronavirus
 
 
NCT04355494: SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19

No Longer Available
N/A
Europe, US
eculizumab, Soliris
Alexion Pharmaceuticals
COVID-19, Pneumonia, Viral, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
 
 
NCT04802083: COVID-19 Soliris Expanded Access Protocol

No Longer Available
N/A
NA
Eculizumab, Soliris, monoclonal antibody
Alexion Pharmaceuticals
Covid19
 
 
NAP, NCT04671810: Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria®

Completed
N/A
44
RoW
Elizaria®, Eculizumab
AO GENERIUM
Paroxysmal Nocturnal Hemoglobinuria
12/22
05/23
NCT05982938: Danicopan Early Access Program

Available
N/A
NA
Danicopan, ALXN2040
Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria, PNH, Extravascular Hemolysis
 
 
SolirisPMS, NCT06448715: Real-World Treatment Study of Soliris (Eculizumab)

Recruiting
N/A
11
RoW
AstraZeneca
Observational
10/24
10/24
m-TMA, NCT06098378: Study of Patients With Thrombotic Microangiopathy Associated With Mitomycin C, Treated or Not With Eculizumab

Recruiting
N/A
30
Europe
University Hospital, Strasbourg, France
Thrombotic Microangiopathies
06/25
06/25
ChiCTR2300067949: The real world study of Eculizumab for paroxysmal nocturnal hemoglobinuria treatment in China

Not yet recruiting
N/A
10
 
Eculizumab
West China Hospitai, Sichuan University; West China Hospitai, Sichuan University, Apply for hospital project funds
paroxysmal nocturnal hemoglobinuria
 
 

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