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Keep this study
Lead
Shire
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.
Age
10–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)