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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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