CLINICAL TRIALS PROFILE FOR ECALLANTIDE
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All Clinical Trials for ecallantide
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00262080 ↗ | Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE) | Completed | Shire | Phase 3 | 2005-12-31 | The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE. |
| NCT00448864 ↗ | Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement | Terminated | Cubist Pharmaceuticals LLC | Phase 2 | 2007-05-01 | The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the first 12 hours postoperatively or until the chest tube was removed, whichever came first, in patients undergoing primary coronary artery bypass grafting (CABG), single valve repair, or single valve replacement. The secondary objective was to compare the efficacy of all ecallantide-treated participants (pooled high and low-doses) to placebo and to compare the high-dose to the low-dose ecallantide group. Other secondary objectives were to evaluate pharmacokinetics and antibody formation. |
| NCT00456508 ↗ | Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE) | Completed | Shire | Phase 3 | 2007-04-01 | The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial. |
| NCT00457015 ↗ | Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE) | Completed | Shire | Phase 3 | 2007-04-01 | The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema. |
| NCT00816023 ↗ | A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume | Completed | Cubist Pharmaceuticals LLC | Phase 2 | 2009-03-01 | The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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