Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)

• Status: Completed
• Trial end date: 2007-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Ecallantide

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