| Berinert (C1 esterase inhibitor (human) IV) / CSL Behring |
2010-019670-32: Pharmacokinetics and Safety of Human Pasteurised C1-Inhibitor Concentrate (Berinert/CE1145) in Subjects with Congenital C1-INH Deficiency. Studio della farmacocinetica e della sicurezza del C1-Inibitore concentrato pasteurizzato umano (Berinert/CE1145) in soggetti con deficienza congenita di C1-INH. |
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| Ongoing | 3 | 3 | Europe | Powder and solvent for solution for injection, BERINERT*IV FL 500U+FL 10ML | AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE), CSL Behring | Hereditary Angioedema (HAE) angioedema ereditario, Hereditary Angioedema (HAE) angioedema ereditario, Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
2020-002225-29: Evaluation of the effects of bradykinin antagonists on pulmonary manifestations of COVID-19 infections. Evaluation des effets des antagonistes de la bradykinine sur les manifestations pulmonaires des infections à COVID-19. |
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| Not yet recruiting | 2 | 45 | Europe | Concentrate and solvent for solution for injection/infusion, Solution for injection in pre-filled syringe, BERINERT, FIRAZYR | Groupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche, Groupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche | COVID positive patients with respiratory impairment Patients COVID + avec atteinte respiratoire, COVID positive patients with respiratory impairment Patients COVID + avec atteinte respiratoire, Diseases [C] - Virus Diseases [C02] | | | | |
| Active, not recruiting | 1/2 | 45 | US | Berinert, C1 Esterase Inhibitor (C1INH), Placebo, Normal Saline | Cedars-Sinai Medical Center, OneLegacy Foundation | End Stage Renal Disease, Chronic Kidney Diseases | 07/22 | 03/24 | | |
| Cinryze IV (C1 esterase inhibitor [human] IV) / Takeda |
CIAO@SAH, NCT06359782: Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage |
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| Not yet recruiting | 2 | 128 | NA | C1 Esterase Inhibitor Injection [Cinryze], Cinryze, Placebo | Haaglanden Medical Centre, Leiden University Medical Center, Takeda | Subarachnoid Hemorrhage, Aneurysmal | 02/27 | 02/27 | | |
NCT02435732: CINRYZE as a Donor Pre-treatment Strategy in Kidney Recipients of KDPI>60% |
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| Not yet recruiting | 1 | 72 | NA | Placebo saline solution, Heparin, CINRYZE, C1INH | University of Wisconsin, Madison, Shire | Kidney Failure | 05/21 | 05/22 | | |
| Ruconest (conestat alfa) / SOBI, Pharming Group |
NCT04705831: Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection |
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| Recruiting | 4 | 40 | US | Ruconest | IMMUNOe Research Centers | Post-Viral Fatigue Syndrome, Post-Viral Disorder (Disorder), Covid19 | 01/22 | 01/22 | | |
| Recruiting | 2 | 150 | Switzerland, Europe and US | Ruconest (conestat alfa) - SOBI, Pharming Group | Pharming Group, Cytobioteck, HyupJin Corporation, SOBI, Megapharm, Bausch Health | Covid-19 | | | | |
2016-005083-34: Conestat alfa as prophylactic treatment for idiopathic non-histaminergic acquired angioedema Conestat alfa (Ruconest®) behandeling voor het voorkómen van angio-oedeem aanvallen bij patiënten met angio-oedeem met onbekende oorzaak |
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| Ongoing | 2 | 10 | Europe | Ruconest, Powder for solution for injection, Ruconest 2100 U powder for solution for injection | University Medical Center Utrecht, Pharming Group N.V., | The medical condition to be investigated is idiopathic non-histaminergic angioedema (InH-AAE). This disease is characterized by recurrent episodes with swelling of the subcutis and mucous membranes. Patient with InH-AAE have by defenition no wheals and are nonresponsive to anti-histamine therapy. Het te onderzoeken ziektebeeld is idiopatisch non-histaminerg verworven angio-oedeem (InH-AAE). Deze aandoening wordt gekenmerkt door recidiverende episodes met zwellingen in de subcutis en mucosa. InH-AAE patienten hebben per definitie geen urticaria en reageren niet op antihistaminica., The medical condition to be investigated is idiopathic non-histaminergic angioedema (InH-AAE). This disease is characterized by recurrent episodes with swelling of the skin and mucous membranes. Het te onderzoeken ziektebeeld is idiopatisch non-histaminerg verworven angio-oedeem (InH-AAE). Deze aandoening wordt gekenmerkt door recidiverende episodes met zwellingen in de subcutis en mucosa., Diseases [C] - Immune System Diseases [C20] | | | | |
2018-002904-14: A study to investigate the tolerance and safety of treatment in patients with preeclampsia Een studie om de tolerantie en veiligheid van behandeling van patienten met zwangerschapsvergiftiging te onderzoeken. |
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| Not yet recruiting | 2 | 30 | Europe | Ruconest, Powder for solution for injection, Ruconest | Pharming Technologies B.V., Pharming Technologies B.V. | Preeclampsia Pre-eclampsie, Preeclampsia Zwangerschapsvergiftiging, Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | | | | |
| Terminated | 2 | 29 | Europe | conestat alfa or placebo, Ruconest | Pharming Technologies B.V. | Non-ST Elevation Myocardial Infarction (NSTEMI) | 04/23 | 04/23 | | |
PAIR-TAVI, NCT05145283: Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation |
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| Recruiting | 2 | 250 | Europe | Conestat alfa (Ruconest®), NaCl 0.9%) | University Hospital, Basel, Switzerland, Swiss National Science Foundation, Pharming Technologies B.V. | Acute Ischemic Stroke, Acute Renal Injury | 03/25 | 03/25 | | |
NCT01397864: C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks |
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| Recruiting | N/A | 300 | Europe, RoW | rhC1INH or pdC1INH, Ruconest | Pharming Technologies B.V. | Hereditary Angioedema | 01/25 | 01/25 | | |
| Enjaymo (sutimlimab) / Sanofi |
| Recruiting | N/A | 400 | Europe, Japan, US | Sutimlimab | Sanofi | Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS) | 11/28 | 11/28 | | |
| riliprubart (SAR445088) / Sanofi |
MOBILIZE, NCT06290128: A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work |
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| Recruiting | 3 | 140 | US | Riliprubart, SAR445088, Placebo | Sanofi | Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Polyneuropathy, Inflammatory Demyelinating, Chronic | 02/26 | 10/27 | | |
VITALIZE, NCT06290141: A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
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| Recruiting | 3 | 160 | US | riliprubart, SAR445088, Placebo, IVIg, IVIg premedication | Sanofi | Chronic Inflammatory Demyelinating Polyneuropathy | 11/25 | 05/27 | | |
2020-004006-54: Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP) |
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| Not yet recruiting | 2 | 158 | Europe | BIVV020, BIVV020, Solution for injection/infusion | Sanofi-Aventis Recherche & Développement, SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT, Sanofi-Aventis Recherche & Développement | Chronic inflammatory demyelinatingpolyneuropathy, Nervous system diseases, Diseases [C] - Nervous System Diseases [C10] | | | | |
2021-000010-41: BIVV020 in prevention and treatment of antibody-mediated rejection (AMR) BIVV020 para la prevención y el tratamiento del rechazo mediado por anticuerpos (RMA) |
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| Ongoing | 2 | 54 | Europe | BIVV020, Solution for injection/infusion | Sanofi-Aventis Recherche & Développement, Sanofi-Aventis Recherche & Développement | Antibody-mediated rejection in adult kidney transplant recipients Rechazo mediado por anticuerpos en adultos receptores de trasplante renal, Renal disease. Enfermedad renal., Diseases [C] - Nervous System Diseases [C10] | | | | |
| Completed | 2 | 12 | Europe, US, RoW | SAR445088 (BIVV020) | Bioverativ, a Sanofi company, Sanofi-Aventis Recherche & Développement | Immune Thrombocytopenia (ITP) | 02/22 | 02/23 | | |
NCT04658472: Proof-of-concept Study for SAR445088 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
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| Active, not recruiting | 2 | 110 | Europe, Canada, US, RoW | SAR445088 (IV), SAR445088 (SC) | Bioverativ, a Sanofi company | Chronic Inflammatory Demyelinating Polyradiculoneuropathy | 08/25 | 08/25 | | |
| Recruiting | 2 | 45 | Europe, Canada, US | BIVV020 (SAR445088), Intravenous immunoglobulin (IVIg), Rituximab or biosimilar, Antithymocyte globulin (ATG), Tacrolimus, Mycophenolate, Corticosteroids | Sanofi, Sanofi-Aventis Recherche & Développement | Transplant Rejection | 11/24 | 12/26 | | |
NCT04802057: Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088 |
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| Active, not recruiting | 1 | 9 | Europe | SAR445088 | Bioverativ, a Sanofi company | Autoimmune Haemolytic Anaemia | 01/26 | 01/26 | | |
| ANX1502 / Annexon Biosci |
| Recruiting | 1 | 84 | Europe | ANX1502, Placebo | Annexon, Inc. | Healthy | 06/23 | 06/23 | | |
