Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Phase 2

• Conditions: Angioedema
• Interventions: Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin

• Registration Number: NCT01036659
• Lead Sponsor: Bernstein, Jonathan A., M.D.

Brief Summary

The investigators will conduct a double-blind, randomized controlled trial comparing the safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design will be used such that patients failing to improve on standard therapy will additionally be treated with ecallantide. Therefore, a historical control cohort will be enrolled for analysis of secondary endpoints. In addition, since some patients treated with conventional therapy may improve rapidly and therefore not be eligible for inclusion in the study, the investigators will enroll these patients as an observational arm to enable the conduct of sensitivity analysis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Study Start: 2010-05
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-08
• Last Update Posted: 2012-03-09
• Primary Completion: 2013-06
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Males and females of any race or ethnicity 18 or older. The locations of the study will permit all racial and ethnic distribution in the study
2. Must currently be on an ACE inhibitor
3. Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF
4. All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.

Exclusion Criteria

1. Participation in another investigational study within 30 days prior to enrollment
2. Patients who improve on conventional (standard of care) therapy
3. Patients previously treated with ecallantide
4. Hypersensitivity to ecallantide
5. Pregnancy or breast feeding
6. Other definable causes of angioedema (i.e., hereditary or acquired angioedema)
7. Patients receiving C-1 inhibitor as prophylaxis
8. Treatment requiring tranexamic acid, and epsilon-aminocaproic acid
9. Receiving fresh frozen plasma within 3 days prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ecallantide in conjunction with Conventional Therapy	ecallantide - Kallikrein inhibitor that blocks the production of bradykinin	-
Conventional therapy and placebo	ecallantide - Kallikrein inhibitor that blocks the production of bradykinin	-

Primary Outcome Measures

Name	Time	Method
Objective criteria that allow for discharge directly from the ED at or before 4 hours:(stable vital signs, no evidence of stridor, dysphagia or drooling, edema has regressed to or did not progress beyond Class I.	18 months

Secondary Outcome Measures

Name	Time	Method
Time to meet objective discharge criteria, Physician assessment of angioedema improvement measured using the Symptom Complex Response Assessment at 2 hours post-treatment and 4 hours post-treatment.	18 months

Trial Locations

Locations (3)

Univeristy Hospital; 🇺🇸 Cincinnati, Ohio, United States

UC Physicians, Dpt of Internal Medicine, Division of Immunology; 🇺🇸 Cincinnati, Ohio, United States

The Jewish Hospital; 🇺🇸 Cincinnati, Ohio, United States