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

March 8, 2012 updated by: Bernstein, Jonathan A., M.D.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45201
        • Recruiting
        • The Jewish Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Moellman, MD
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Univeristy Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jonathan A Bernstein, MD
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • UC Physicians, Dpt of Internal Medicine, Division of Immunology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ecallantide in conjunction with Conventional Therapy
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.
Placebo Comparator: Conventional therapy and placebo
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.
No Intervention: Historical Evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bernstein, Jonathan A., M.D.

Collaborators

Dyax Corp.

Investigators

  • Principal Investigator: Jonathan A. Bernstein, M.D., UC Physicians, Division of Immunology
  • Principal Investigator: Joseph Moellman, MD, UC Physicians, Department of Emergency Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 18, 2009

First Submitted That Met QC Criteria

December 18, 2009

First Posted (Estimate)

December 21, 2009

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACE Induced Angioedema

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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