Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema - Full Text View

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:

Drug Information available for: Ecallantide

U.S. FDA Resources

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:

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
Must currently be on an ACE inhibitor
Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF
All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.

Exclusion Criteria:

Participation in another investigational study within 30 days prior to enrollment
Patients who improve on conventional (standard of care) therapy
Patients previously treated with ecallantide
Hypersensitivity to ecallantide
Pregnancy or breast feeding
Other definable causes of angioedema (i.e., hereditary or acquired angioedema)
Patients receiving C-1 inhibitor as prophylaxis
Treatment requiring tranexamic acid, and epsilon-aminocaproic acid
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 May 16, 2013

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