CLINICAL TRIALS PROFILE FOR RUCONEST
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All Clinical Trials for RUCONEST
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00225147 ↗ | Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema | Completed | Pharming Technologies B.V. | Phase 2/Phase 3 | 2005-07-01 | Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that lead to a decrease in the blood level of functional "C1INH". This multi-center study was designed to assess the safety and tolerability, efficacy, and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema attacks. Funding Source - FDA OOPD |
| NCT00262301 ↗ | Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema | Completed | Pharming Technologies B.V. | Phase 3 | 2004-06-01 | Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that leads to a decrease in the blood level of functional "C1INH". This multi-center study was designed to assess the safety and tolerability, efficacy and pharmacodynamics/ pharmacokinetics of recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema attacks. |
| NCT00851409 ↗ | A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration | Completed | Pharming Technologies B.V. | Phase 2 | 2009-06-01 | Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study aims to evaluate the safety and prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor ("rhC1INH"). |
| NCT01359969 ↗ | Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients | Completed | Pharming Technologies B.V. | Phase 2 | 2012-01-17 | This open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including 13 years of age. |
| NCT01397864 ↗ | C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks | Recruiting | Pharming Technologies B.V. | 2011-07-01 | This is a non-interventional treatment Registry of Hereditary Angioedema (HAE) patients treated with C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (rhC1INH / Ruconest), to observe adverse events and insufficient efficacy, and to assess the immunological profile following single and repeated treatment with Ruconest. | |
| NCT03791476 ↗ | RUCONEST® as a Therapeutic Strategy to Reduce the Incidence of Delayed Graft Function | Recruiting | Pharming Technologies B.V. | Phase 1 | 2019-06-21 | An unmet medical need exists for therapeutic regimens in transplantation that allow immediate postoperative graft function, thereby improving graft survival. Delayed graft function (DGF) after transplantation is the most common complication affecting kidney allographs in the immediate transplant period. The specific aim of this study is to evaluate the effect of recombinant human C1-inhibitor (rhC1INH), as a kidney recipient intra- and post operative treatment strategy to decrease systemic inflammation and decrease the incidence of DGF from donation after cardiac death donors (DCD). |
| NCT03791476 ↗ | RUCONEST® as a Therapeutic Strategy to Reduce the Incidence of Delayed Graft Function | Recruiting | University of Wisconsin, Madison | Phase 1 | 2019-06-21 | An unmet medical need exists for therapeutic regimens in transplantation that allow immediate postoperative graft function, thereby improving graft survival. Delayed graft function (DGF) after transplantation is the most common complication affecting kidney allographs in the immediate transplant period. The specific aim of this study is to evaluate the effect of recombinant human C1-inhibitor (rhC1INH), as a kidney recipient intra- and post operative treatment strategy to decrease systemic inflammation and decrease the incidence of DGF from donation after cardiac death donors (DCD). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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