13 completed, 2 terminated, 2 unknown, 1 withdrawn. 11 Phase 2, 3 Phase 3, 2 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 11 | Completed 8, Terminated 2, Withdrawn 1 |
| Phase 3 | 3 | Completed 2, Unknown 1 |
| Phase 1 | 2 | Completed 1, Unknown 1 |
| Phase 4 | 1 | Completed 1 |
Follow conestat alfa: new trials by email Literature Review of conestat alfa trials Research Report on conestat alfa
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 |
|---|---|---|---|---|---|---|
| Safety and Efficacy of Conestat Alfa for ACE-Induced Angioedema Conestat Alfa - ACE Inhibitor-Induced Angioedema | Phase 3 | Unknown | University of Cincinnati | 24 | 2024-12-01 | 2024-11-07 |
| Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation Conestat alfa (Ruconest®), NaCl 0.9%) - Acute Ischemic Stroke, Acute Renal Injury | Phase 2 | Completed | University Hospital, Basel, Switzerland | 141 | 2022-03-16 | 2026-04-22 |
| Prevention of Acute Kidney Injury in Patients With NSTEMI conestat alfa or placebo - Non-ST Elevation Myocardial Infarction (NSTEMI) | Phase 2 | Terminated | Pharming Technologies B.V. | 29 | 2021-04-21 | 2024-04-03 |
| Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection Ruconest - Post-Viral Fatigue Syndrome, Post-Viral Disorder (Disorder) | Phase 2 | Completed | IMMUNOe Research Centers | 40 | 2021-01-11 | 2025-08-11 |
| Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19 Ruconest - Confirmed Coronavirus Disease | Phase 2 | Completed | Pharming Technologies B.V. | 38 | 2020-11-30 | 2024-02-16 |
| Conestat Alfa in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19 Conestat alfa - Coronavirus Infections | Phase 2 | Terminated | University Hospital, Basel, Switzerland | 80 | 2020-08-06 | 2021-11-09 |
| RUCONEST® as a Therapeutic Strategy to Reduce the Incidence of Delayed Graft Function rhC1INH, Saline Solution - Kidney Failure | Phase 1 | Unknown | University of Wisconsin, Madison | 20 | 2019-06-21 | 2020-12-14 |
| Treatment of Hereditary Angioedema Prodrome with Recombinant C1-esterase Inhibitor (Ruconest) Ruconest - Hereditary Angioedema | Phase 4 | Completed | Bernstein Clinical Research Center | 5 | 2018-08-14 | 2024-11-15 |
| Patient Registry to Evaluate the Real-world Safety of Ruconest® rhC1INH - Hereditary Angioedema | Completed | Pharming Technologies B.V. | 152 | 2018-06-30 | 2024-04-05 | |
| Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy in High-risk Subjects Conestat alfa, Sodium chloride 0.9% - Acute Kidney Injury | Phase 2 | Completed | University Hospital, Basel, Switzerland | 80 | 2017-01-01 | 2018-08-08 |
| Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects Recombinant human C1 esterase inhibitor, Placebo, SHP623 - Hereditary Angioedema (HAE) | Phase 1 | Completed | Shire | 48 | 2016-02-19 | 2021-06-03 |
| 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 |
| Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients rhC1INH - Hereditary Angioedema | Phase 2 | Completed | Pharming Technologies B.V. | 57 | 2012-01-17 | 2024-03-29 |
| C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks rhC1INH or pdC1INH - Hereditary Angioedema | Completed | Pharming Technologies B.V. | 181 | 2011-07-01 | 2025-04-08 | |
| Recombinant Human C1 Inhibitor for the Treatment of Early Antibody-Mediated Rejection in Renal Transplantation plasmapheresis and IVIG, recombinant C1 inhibitor - Graft Rejection, Kidney Transplantation | Phase 2 | Withdrawn | Pharming Technologies B.V. | 2010-12-01 | 2012-02-17 | |
| A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration Recombinant Human C1 Inhibitor - Genetic Disorders, Hereditary Angioedema | Phase 2 | Completed | Pharming Technologies B.V. | 25 | 2009-06-01 | 2018-06-26 |
| Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema Recombinant Human C1 Inhibitor, placebo - Hereditary Angioedema, Angioneurotic Edema | Phase 2 / Phase 3 | Completed | Pharming Technologies B.V. | 77 | 2005-07-01 | 2013-02-22 |
| Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema recombinant human C1 inhibitor, Placebo - Hereditary Angioedema, Angioneurotic Edema | Phase 3 | Completed | Pharming Technologies B.V. | 75 | 2004-06-01 | 2012-10-02 |
Angioedemas, Hereditary (10) · Angioedema (5) · Acute Kidney Injury (2) · COVID-19 (2) · Genetic Diseases, Inborn (2) · Aortic Valve Stenosis (1) · Coronavirus Infections (1) · Cytokine Release Syndrome (1) · Delayed Graft Function (1) · Fatigue Syndrome, Chronic (1) · Heart Valve Diseases (1) · Inflammation (1) · Ischemic Stroke (1) · Non-ST Elevated Myocardial Infarction (1) · Renal Insufficiency (1)
Pharming Technologies B.V. (10) · University Hospital, Basel, Switzerland (3) · Bernstein Clinical Research Center (1) · IMMUNOe Research Centers (1) · Shire (1) · University of Cincinnati (1) · University of Wisconsin, Madison (1)
United States (9) · Romania (4) · Switzerland (4) · Czechia (3) · Italy (3) · Netherlands (3) · North Macedonia (3) · Germany (2) · Hungary (2) · Poland (2) · Slovakia (2) · Brazil (1) · Bulgaria (1) · Canada (1) · Croatia (1)
Anurag Relan, MD (5) · Jonathan Bernstein, MD (2) · Bruno Giannetti, MD (1) · Gentry Wilkerson, MD (1) · Hans Sollinger, MD, PhD (1) · Jan Nuijens, MD, PhD (1) · Joseph A. Moellman, MD (1) · Luis Fernandez (1) · Michael Osthoff, M.D. (1) · Michael Osthoff, PD Dr. med. (1) · Michael Osthoff, Prof. Dr. med. (1) · Raban Jeger, Prof. Dr. med. (1)
PMID 20920772, PMID 28284978, PMID 42159953, PMID 22909164, PMID 23535096, PMID 28754491, PMID 30993784, PMID 32171721, PMID 33397449, PMID 36326435, PMID 37965347, PMID 41281561