Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-26 @ 12:44 PM
Study NCT ID:
NCT01036659
Status:
UNKNOWN
Last Update Posted:
2012-03-09
First Post:
2009-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-11-04', 'releaseDate': '2014-10-30'}], 'estimatedResultsFirstSubmitDate': '2014-10-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000799', 'term': 'Angioedema'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-08', 'studyFirstSubmitDate': '2009-12-18', 'studyFirstSubmitQcDate': '2009-12-18', 'lastUpdatePostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute angiotensin converting enzyme inhibitor angioedema'], 'conditions': ['Angioedema']}, 'referencesModule': {'references': [{'pmid': '25601538', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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\n2. Must currently be on an ACE inhibitor\n3. Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF\n4. All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.\n\nExclusion Criteria:\n\n1. Participation in another investigational study within 30 days prior to enrollment\n2. Patients who improve on conventional (standard of care) therapy\n3. Patients previously treated with ecallantide\n4. Hypersensitivity to ecallantide\n5. Pregnancy or breast feeding\n6. Other definable causes of angioedema (i.e., hereditary or acquired angioedema)\n7. Patients receiving C-1 inhibitor as prophylaxis\n8. Treatment requiring tranexamic acid, and epsilon-aminocaproic acid\n9. Receiving fresh frozen plasma within 3 days prior to enrollment'}, 'identificationModule': {'nctId': 'NCT01036659', 'acronym': 'ACE', 'briefTitle': 'Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema', 'organization': {'class': 'INDIV', 'fullName': 'Bernstein, Jonathan A., M.D.'}, 'officialTitle': 'Evaluation of Ecallantide for Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema', 'orgStudyIdInfo': {'id': 'ACE Induced Angioedema'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ecallantide in conjunction with Conventional Therapy', 'interventionNames': ['Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional therapy and placebo', 'interventionNames': ['Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin']}, {'type': 'NO_INTERVENTION', 'label': 'Historical Evaluation'}], 'interventions': [{'name': 'ecallantide - Kallikrein inhibitor that blocks the production of bradykinin', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Conventional therapy and placebo', 'Ecallantide in conjunction with Conventional Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45201', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jillian K Picard, RN, BSN', 'role': 'CONTACT', 'email': 'Jillian.picard@uc.edu', 'phone': '513-558-0924'}, {'name': 'Sarah J Holmes, RN, BSN', 'role': 'CONTACT', 'email': 'Sarah.holmes@uc.edu', 'phone': '513-558-0924'}, {'name': 'Joseph Moellman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Jewish Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jillian K Picard, RN, BSN', 'role': 'CONTACT', 'email': 'Jillian.picard@uc.edu', 'phone': '513-558-0924'}, {'name': 'Sarah J Holmes, RN, BSN', 'role': 'CONTACT', 'email': 'Sarah.holmes@uc.edu', 'phone': '513-558-0924'}, {'name': 'Jonathan A Bernstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Univeristy Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jillian Picard, RN', 'role': 'CONTACT', 'email': 'jillian.picard@uc.edu', 'phone': '513-558-0924'}, {'name': 'Sarah J. Holmes, RN', 'role': 'CONTACT', 'email': 'sarah.holmes@uc.edu', 'phone': '513-558-0924'}], 'facility': 'UC Physicians, Dpt of Internal Medicine, Division of Immunology', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Jillian Picard, RN', 'role': 'CONTACT', 'email': 'jillian.picard@uc.edu', 'phone': '513-558-0924'}, {'name': 'Sarah J. Holmes, RN', 'role': 'CONTACT', 'email': 'sarah.holmes@uc.edu', 'phone': '513-558-0924'}], 'overallOfficials': [{'name': 'Jonathan A. Bernstein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Physicians, Division of Immunology'}, {'name': 'Joseph Moellman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Physicians, Department of Emergency Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bernstein, Jonathan A., M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'Dyax Corp.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Jonathan a. Bernstein, M.D.', 'oldOrganization': 'UC Physicians, Department of Internal Medicine Division of Immunology'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-10-30', 'type': 'RELEASE'}, {'date': '2014-11-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jonathan A. Bernstein, MD, Jonathan A. Bernstein, MD, Bernstein, Jonathan A., M.D.'}}}}