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

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ClinicalTrials.gov Identifier: NCT01036659
Recruitment Status : Unknown
Verified March 2012 by Bernstein, Jonathan A., M.D..
Recruitment status was:  Recruiting
First Posted : December 21, 2009
Last Update Posted : March 9, 2012
Sponsor:
Collaborator:
Dyax Corp.
Information provided by:
Bernstein, Jonathan A., M.D.

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Ecallantide for Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Study Start Date : May 2010
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ecallantide
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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         
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         
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   
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

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
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Bradykinin
Kallikreins
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Vasodilator Agents
Coagulants
Fertility Agents, Male
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs