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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Bernstein, Jonathan A., M.D..
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention Phase
Angioedema
Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Ecallantide for Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Resource links provided by NLM:


Further study details as provided by Bernstein, Jonathan A., M.D.:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036659

Contacts
Contact: Jillian Picard, RN 513-558-0924 jillian.picard@uc.edu
Contact: Sarah J. Holmes, RN 513-558-0924 sarah.holmes@uc.edu

Locations
United States, Ohio
UC Physicians, Dpt of Internal Medicine, Division of Immunology Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Jillian Picard, RN    513-558-0924    jillian.picard@uc.edu   
Contact: Sarah J. Holmes, RN    513-558-0924    sarah.holmes@uc.edu   
Univeristy Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Jillian K Picard, RN, BSN    513-558-0924    Jillian.picard@uc.edu   
Contact: Sarah J Holmes, RN, BSN    513-558-0924    Sarah.holmes@uc.edu   
Principal Investigator: Jonathan A Bernstein, MD         
The Jewish Hospital Recruiting
Cincinnati, Ohio, United States, 45201
Contact: Jillian K Picard, RN, BSN    513-558-0924    Jillian.picard@uc.edu   
Contact: Sarah J Holmes, RN, BSN    513-558-0924    Sarah.holmes@uc.edu   
Principal Investigator: Joseph Moellman, MD         
Sponsors and Collaborators
Bernstein, Jonathan A., M.D.
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
  More Information

No publications provided

Responsible Party: Jonathan a. Bernstein, M.D., UC Physicians, Department of Internal Medicine Division of Immunology
ClinicalTrials.gov Identifier: NCT01036659     History of Changes
Other Study ID Numbers: ACE Induced Angioedema
Study First Received: December 18, 2009
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bernstein, Jonathan A., M.D.:
acute angiotensin converting enzyme inhibitor angioedema

Additional relevant MeSH terms:
Angioedema
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Angiotensin-Converting Enzyme Inhibitors
Bradykinin
Enzyme Inhibitors
Kallikreins
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Coagulants
Hematologic Agents
Fertility Agents, Male
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014