33 completed, 4 terminated, 2 recruiting, 1 withdrawn. 17 Phase 2, 16 Phase 3, 6 Phase 1, 4 Phase 4, 1 Early Phase 1.
Follow Complement C1 Inhibitor Protein: new trials by email Literature Review of Complement C1 Inhibitor Protein trials Research Report on Complement C1 Inhibitor Protein
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (IMPROVE TRIAL) Berinert, Placebo for Berinert - Kidney Transplant | Phase 2 | Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 180 | 2025-09-22 | 2026-02-27 |
| Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH) C1 Esterase Inhibitor Injection [Cinryze], Placebo - Subarachnoid Hemorrhage, Aneurysmal | Phase 2 | Recruiting | Haaglanden Medical Centre | 128 | 2024-11-04 | 2024-12-27 |
| Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema GNR-038, 50 МЕ/ kg, GNR-038, 100 МЕ/ kg, Berinert®, 20 МЕ/ kg - Hereditary Angioedema | Phase 2 / Phase 3 | Withdrawn | AO GENERIUM | 2021-12-01 | 2022-02-04 | |
| Berinert (C1INH) vs Placebo for DGF/IRI Berinert, Placebo - End Stage Renal Disease, Chronic Kidney Diseases | Phase 1 / Phase 2 | Completed | Cedars-Sinai Medical Center | 45 | 2021-03-03 | 2024-12-04 |
| Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study). C1 Inhibitor Human, Icatibant Injection, Placebo - Covid19 | Phase 2 | Completed | GCS Ramsay Santé pour l'Enseignement et la Recherche | 44 | 2021-02-04 | 2022-12-22 |
| A Study to Evaluate the Benefit of RUCONEST® in Subjects Who Experience ADRs Related to IVIG Infusions C1-esterase inhibitor [recombinant] (C1-INH-R) - CVI - Common Variable Immunodeficiency | Phase 4 | Completed | IMMUNOe Research Centers | 20 | 2018-06-13 | 2021-02-15 |
| Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients C1-esterase inhibitor, Placebo - Antibody-mediated Rejection | Phase 3 | Terminated | CSL Behring | 63 | 2017-11-06 | 2022-07-29 |
| C1-inhibitor in Allergic ASThma Patients C1-inhibitor, Saline, Antibiotics - Asthma | Phase 4 | Terminated | T. van der Poll | 37 | 2016-11-16 | 2020-06-24 |
| C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection C1-INH (Berinert) - Antibody Mediated Rejection of Kidney Transplant | Phase 2 | Completed | NYU Langone Health | 1 | 2016-10-01 | 2019-07-11 |
| Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema C1 esterase inhibitor [human] liquid, Placebo - Hereditary Angioedema (HAE) | Phase 3 | Completed | Shire | 75 | 2015-11-01 | 2021-06-08 |
| A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema C1-esterase inhibitor - Hereditary Angioedema Types I and II | Phase 3 | Completed | CSL Behring | 126 | 2014-12-31 | 2018-11-14 |
| A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor Recombinant human C1 inhibitor, Placebo - Hereditary Angioedema | Phase 2 | Completed | Pharming Technologies B.V. | 32 | 2014-12-01 | 2017-12-08 |
| Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL) Antithrombin-III, Infliximab, Apotransferrin - Reperfusion Injury | Phase 2 | Completed | Universitaire Ziekenhuizen KU Leuven | 143 | 2014-09-01 | 2024-08-23 |
| C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI C1 Esterase Inhibitor, Placebo - End Stage Renal Disease, Kidney Failure | Phase 1 / Phase 2 | Completed | Cedars-Sinai Medical Center | 70 | 2014-09-01 | 2018-06-25 |
| Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema Berinert, Clemastin, Cortisone acetate - Acute ACE-induced Angioedema | Phase 3 | Completed | Technical University of Munich | 31 | 2013-11-01 | 2023-11-24 |
| In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II C1-esterase inhibitor, Endotoxin - Innate Immune Response, Endotoxemia | Phase 3 | Completed | Radboud University Medical Center | 20 | 2013-09-01 | 2014-12-02 |
| Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks CINRYZE with rHuPH20 - Hereditary Angioedema (HAE) | Phase 2 | Completed | Shire | 47 | 2013-02-04 | 2021-06-03 |
| A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor Berinert, CSL830 - Hereditary Angioedema Types I and II | Phase 1 | Completed | CSL Behring | 16 | 2013-01-01 | 2013-04-05 |
| C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation C1-esterase inhibitor (Cinryze) - Neuromyelitis Optica | Phase 1 | Completed | Michael Levy | 10 | 2013-01-01 | 2014-07-18 |
| Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor M5, C1-inhibitor - Acute Ischemic Stroke | Early Phase 1 | Terminated | TSI, LLC | 8 | 2012-09-01 | 2021-01-19 |
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Angioedemas, Hereditary (25) · Angioedema (3) · Genetic Diseases, Inborn (3) · Hereditary Angioedema Types I and II (3) · Inflammation (3) · Sepsis (3) · Endotoxemia (2) · Kidney Failure, Chronic (2) · Renal Insufficiency, Chronic (2) · Asthma (1) · Brain Infarction (1) · Brain Ischemia (1) · COVID-19 (1) · Cardiovascular Diseases (1) · Cerebral Infarction (1)
Shire (11) · CSL Behring (7) · Pharming Technologies B.V. (4) · Cedars-Sinai Medical Center (2) · Radboud University Medical Center (2) · AO GENERIUM (1) · GCS Ramsay Santé pour l'Enseignement et la Recherche (1) · Haaglanden Medical Centre (1) · IMMUNOe Research Centers (1) · Johann Wolfgang Goethe University Hospital (1) · Michael Levy (1) · NYU Langone Health (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · Stanley Jordan, MD (1) · T. van der Poll (1)
United States (24) · Germany (10) · Netherlands (10) · Romania (7) · Canada (5) · Hungary (5) · Spain (5) · Czechia (3) · Israel (3) · United Kingdom (3) · Australia (2) · Belgium (2) · Bulgaria (2) · France (2) · Italy (2)
Stanley C Jordan, MD (2) · Anurag Relan, MD (1) · Ashley Vo, PharmD (1) · Bruno Giannetti, MD (1) · Diethard Monbaliu, MD, PhD (1) · Hans Hoeven, Prof (1) · Isaac Melamed, MD (1) · Jan Nuijens, MD, PhD (1) · Koos Burggraaf, MD, PhD (1) · Luke P Leenen, MD, PhD (1) · Michael Levy, MD, PhD (1)
PMID 36326435, PMID 20818886, PMID 23312695, PMID 20920772, PMID 22856635, PMID 23484892, PMID 23987198, PMID 28284978, PMID 42159953, PMID 19767078, PMID 20674826, PMID 21195947, PMID 21884533, PMID 21988742, PMID 22192966, PMID 22856636, PMID 22909164, PMID 23535096, PMID 24266596, PMID 25191939, PMID 25295804, PMID 25606785, PMID 25609333, PMID 26171584, PMID 27184779, PMID 27699634, PMID 27788880, PMID 27931305, PMID 28515092, PMID 28754491, PMID 30682573, PMID 30772477, PMID 32042283, PMID 33332922, PMID 33588897, PMID 33737935, PMID 34303860, PMID 36853611, PMID 40349965, PMID 40972903
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