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.
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.
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.
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