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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

Page last updated: August 23, 2015

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