Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)
Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)
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.
This is an open label trial.

 The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in
 the treatment of acute attacks of hereditary angioedema. This study is designed to provide
 efficacy and safety data on repeated use of ecallantide. These data are intended to support
 the marketing authorization of ecallantide in the treatment of acute attacks of hereditary
 angioedema. Efficacy and safety of ecallantide will be evaluated in this study.
Inclusion Criteria:

 -  10 years of age or older

 -  Documented diagnosis of HAE (Type I or II)

 -  Willing and able to give informed consent

 -  Acute HAE attack at time of presentation

 Exclusion Criteria:

 -  Receipt of an investigational drug or device, within 30 days prior to study treatment,
 other than DX-88 (ecallantide)

 -  Pregnancy or breastfeeding

 -  Receipt of non-investigational C1-INH or DX-88 within 72 hours of treatment

 -  Patients eligible for current, ongoing clinical trial in which DX 88 (ecallantide) is
 offered