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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.

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

Details

• Lead Sponsor: Shire
• Treatments: Ecallantide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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