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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.

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

Details

• Lead Sponsor: Shire
• Treatments: Ecallantide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• Pregnancy or breastfeeding