Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
NCT ID: NCT01036659
Last Updated: 2012-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2010-05-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ecallantide in conjunction with Conventional Therapy
ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
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.
Conventional therapy and placebo
ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
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.
Historical Evaluation
No interventions assigned to this group
Interventions
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ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Dyax Corp.
INDUSTRY
Bernstein, Jonathan A., M.D.
INDIV
Responsible Party
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UC Physicians, Department of Internal Medicine Division of Immunology
Principal Investigators
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Jonathan A. Bernstein, M.D.
Role: PRINCIPAL_INVESTIGATOR
UC Physicians, Division of Immunology
Joseph Moellman, MD
Role: PRINCIPAL_INVESTIGATOR
UC Physicians, Department of Emergency Medicine
Locations
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The Jewish Hospital
Cincinnati, Ohio, United States
Univeristy Hospital
Cincinnati, Ohio, United States
UC Physicians, Dpt of Internal Medicine, Division of Immunology
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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ACE Induced Angioedema
Identifier Type: -
Identifier Source: org_study_id
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