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

Study Overview
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Brief Summary
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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.

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

Conditions
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Angioedema

Intervention / Treatment
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* Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Must currently be on an ACE inhibitor Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF All females of childbearing age must have a negative pregnancy test prior to administration of the study drug. Exclusion Criteria: Participation in another investigational study within 30 days prior to enrollment Patients who improve on conventional (standard of care) therapy Patients previously treated with ecallantide Hypersensitivity to ecallantide Pregnancy or breast feeding Other definable causes of angioedema (i.e., hereditary or acquired angioedema) Patients receiving C-1 inhibitor as prophylaxis Treatment requiring tranexamic acid, and epsilon-aminocaproic acid Receiving fresh frozen plasma within 3 days prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ecallantide in conjunction with Conventional Therapy<br> | Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin<br>* subcutaneous dose of 30mg of ecallantide or placebo (three 10 mg SC injections at three different sites ((arms, legs, abdomen). Injections are not to be administered at the attack location.<br>|
| Placebo Comparator: Conventional therapy and placebo<br> | Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin<br>* subcutaneous dose of 30mg of ecallantide or placebo (three 10 mg SC injections at three different sites ((arms, legs, abdomen). Injections are not to be administered at the attack location.<br>|
| No Intervention: Historical Evaluation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute angiotensin converting enzyme inhibitor angioedema