EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients with Hereditary Angioedema.

• Phase: Phase 2
• 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)

• Patient reported to a study site no later than 4 hours following patient recognition of the onset of the attack

• Willing and able to give informed consent

Exclusion Criteria:

• Patients with a serious intercurrent illness or serious active infection

• Patient with serum creatinine greater than 110% the upper limit of normal or liver transaminases 2 times the upper limit of normal

• Receipt of an investigational drug or device, within 30 days prior to study treatment

• Pregnancy or breastfeeding

• Diagnosis of acquired angioedema (AAE)

• Patients who had not completed their Day-7 follow-up procedures for a previously treated attack