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| Name | Class |
|---|---|
| Dyax Corp. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ecallantide in conjunction with Conventional Therapy | Active Comparator |
| |
| Conventional therapy and placebo | Placebo Comparator |
| |
| Historical Evaluation | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ecallantide - Kallikrein inhibitor that blocks the production of bradykinin | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jillian Picard, RN | Contact | 513-558-0924 | jillian.picard@uc.edu | |
| Sarah J. Holmes, RN | Contact | 513-558-0924 | sarah.holmes@uc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan A. Bernstein, M.D. | UC Physicians, Division of Immunology | Principal Investigator |
| Joseph Moellman, MD | UC Physicians, Department of Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Jewish Hospital | Recruiting | Cincinnati | Ohio | 45201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25601538 | Derived | Bernstein JA, Moellman JJ, Collins SP, Hart KW, Lindsell CJ. Effectiveness of ecallantide in treating angiotensin-converting enzyme inhibitor-induced angioedema in the emergency department. Ann Allergy Asthma Immunol. 2015 Mar;114(3):245-9. doi: 10.1016/j.anai.2014.12.007. Epub 2015 Jan 16. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 30, 2014 | |
| Reset | Nov 4, 2014 |
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| Univeristy Hospital | Recruiting | Cincinnati | Ohio | 45219 | United States |
|
| UC Physicians, Dpt of Internal Medicine, Division of Immunology | Recruiting | Cincinnati | Ohio | 45267 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 30, 2014 | Nov 4, 2014 |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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