Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shire
This is a randomized placebo-controlled trial.
The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema. This study is conducted under Special Protocol Assessment with the FDA and is designed to provide pivotal efficacy data on 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
Executed informed consent
Documented diagnosis of HAE (Type I or II)
Presentation at the site within 8 hours of patient recognition of an moderate to severe HAE acute attack
You may not be if
Receipt of an investigational drug or device, within 30 days prior to study treatment
Receipt of non-investigational C1-INH within 7 days of treatment
Receipt of DX-88 (ecallantide) within 3 days prior to study treatment
Diagnosis of acquired angioedema (AAE), estrogen-dependent angioedema or drug-induced angioedema (including angiotensin-converting enzyme inhibitor induced angioedema)
