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

This study is currently recruiting participants.
Verified March 2012 by Bernstein, Jonathan A., M.D.
Sponsor:
Collaborator:
Dyax Corp.
Information provided by:
Bernstein, Jonathan A., M.D.
ClinicalTrials.gov Identifier:
NCT01036659
First received: December 18, 2009
Last updated: March 8, 2012
Last verified: March 2012
History of Changes

December 18, 2009
March 8, 2012
May 2010
June 2013   (final data collection date for primary outcome 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. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01036659 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Angioedema
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.
  • Active Comparator: Ecallantide in conjunction with Conventional Therapy
    Intervention: Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
  • Placebo Comparator: Conventional therapy and placebo
    Intervention: Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
  • No Intervention: Historical Evaluation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Jillian Picard, RN 513-558-0924 jillian.picard@uc.edu
Contact: Sarah J. Holmes, RN 513-558-0924 sarah.holmes@uc.edu
United States
 
NCT01036659
ACE Induced Angioedema
Yes
Jonathan a. Bernstein, M.D., UC Physicians, Department of Internal Medicine Division of Immunology
Bernstein, Jonathan A., M.D.
Dyax Corp.
Principal Investigator: Jonathan A. Bernstein, M.D. UC Physicians, Division of Immunology
Principal Investigator: Joseph Moellman, MD UC Physicians, Department of Emergency Medicine
Bernstein, Jonathan A., M.D.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP