Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Information source: Bernstein, Jonathan A., M.D.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Angioedema
Intervention: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Bernstein, Jonathan A., M.D. Official(s) and/or principal investigator(s): Jonathan A. Bernstein, M.D., Principal Investigator, Affiliation: UC Physicians, Division of Immunology Joseph Moellman, MD, Principal Investigator, Affiliation: UC Physicians, Department of Emergency Medicine
Overall contact: Jillian Picard, RN, Phone: 513-558-0924, Email: jillian.picard@uc.edu
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.
Clinical Details
Official title: Evaluation of Ecallantide for Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jillian Picard, RN, Phone: 513-558-0924, Email: jillian.picard@uc.edu
The Jewish Hospital, Cincinnati, Ohio 45201, United States; Recruiting Jillian K Picard, RN, BSN, Phone: 513-558-0924, Email: Jillian.picard@uc.edu Sarah J Holmes, RN, BSN, Phone: 513-558-0924, Email: Sarah.holmes@uc.edu Joseph Moellman, MD, Principal Investigator
UC Physicians, Dpt of Internal Medicine, Division of Immunology, Cincinnati, Ohio 45267, United States; Recruiting Jillian Picard, RN, Phone: 513-558-0924, Email: jillian.picard@uc.edu Sarah J. Holmes, RN, Phone: 513-558-0924, Email: sarah.holmes@uc.edu
Univeristy Hospital, Cincinnati, Ohio 45219, United States; Recruiting Jillian K Picard, RN, BSN, Phone: 513-558-0924, Email: Jillian.picard@uc.edu Sarah J Holmes, RN, BSN, Phone: 513-558-0924, Email: Sarah.holmes@uc.edu Jonathan A Bernstein, MD, Principal Investigator
Additional Information
Starting date: May 2010
Last updated: March 8, 2012
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