Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)
Hereditary Angioedema (HAE)
About this trial
This is an interventional treatment trial for Hereditary Angioedema (HAE)
Eligibility Criteria
Inclusion Criteria: Age 10 and older Documented diagnosis of HAE, Type I or II Executed informed consent Presentation for treatment within 8 hours of patient recognition of moderate to severe HAE attack Exclusion Criteria: Receipt of investigational drug or device, other than DX-88, within 30 days of treatment Receipt of non-investigational C1-INH (C1 esterase inhibitor) within 7 days of treatment Diagnostic of acquired angioedema, estrogen-dependent angioedema or drug induced angioedema Pregnancy or breastfeeding Patients who have received DX-88 within 7 days of presentation for dosing in the Double-blind Phase
Sites / Locations
- Institute for Asthma and Allergy
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
DX-88 (ecallantide)
Placebo
DX-88 (ecallantide) 30 mg given as three 10 mg/mL subcutaneous injections.
Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.