Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Overview

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.

Full Title of Study: “Evaluation of Ecallantide for Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 2013

Interventions

  • Drug: 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.

Arms, Groups and Cohorts

  • Active Comparator: Ecallantide in conjunction with Conventional Therapy
  • Placebo Comparator: Conventional therapy and placebo
  • No Intervention: Historical Evaluation

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 18 months

Secondary Measures

  • 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.
    • Time Frame: 18 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bernstein, Jonathan A., M.D.
  • Collaborator
    • Dyax Corp.
  • Provider of Information About this Clinical Study
    • Jonathan a. Bernstein, M.D., UC Physicians, Department of Internal Medicine Division of Immunology
  • Overall Official(s)
    • Jonathan A. Bernstein, M.D., Principal Investigator, UC Physicians, Division of Immunology
    • Joseph Moellman, MD, Principal Investigator, UC Physicians, Department of Emergency Medicine
  • Overall Contact(s)
    • Jillian Picard, RN, 513-558-0924, jillian.picard@uc.edu

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