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

NCT01036659 | Unknown Phase 2 DMC

• 1 other identifier: ACE Induced Angioedema
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Angioedema

Keywords

acute angiotensin converting enzyme inhibitor angioedema

Outcome Measures

Primary Outcomes (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.

  18 months

Secondary Outcomes (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.

  18 months

Study Arms (3)

Ecallantide in conjunction with Conventional Therapy

ACTIVE COMPARATOR

Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin

Conventional therapy and placebo

PLACEBO COMPARATOR

Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin

Historical Evaluation

NO INTERVENTION

Interventions

ecallantide - Kallikrein inhibitor that blocks the production of bradykinin DRUG

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.

Conventional therapy and placebo; Ecallantide in conjunction with Conventional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bernstein, Jonathan A., M.D.: lead
• Dyax Corp.: collaborator

Study Sites (3)

The Jewish Hospital

Cincinnati, Ohio, 45201, United States

RECRUITING

Univeristy Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

UC Physicians, Dpt of Internal Medicine, Division of Immunology

Cincinnati, Ohio, 45267, United States

RECRUITING

Related Publications (1)

• Bernstein JA, Moellman JJ, Collins SP, Hart KW, Lindsell CJ. Effectiveness of ecallantide in treating angiotensin-converting enzyme inhibitor-induced angioedema in the emergency department. Ann Allergy Asthma Immunol. 2015 Mar;114(3):245-9. doi: 10.1016/j.anai.2014.12.007. Epub 2015 Jan 16.

  PMID: 25601538 DERIVED

MeSH Terms

Conditions

Angioedema

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jonathan A. Bernstein, M.D.

  UC Physicians, Division of Immunology

  PRINCIPAL INVESTIGATOR

• Joseph Moellman, MD

  UC Physicians, Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jillian Picard, RN

CONTACT

513-558-0924; jillian.picard@uc.edu

Sarah J. Holmes, RN

CONTACT

513-558-0924; sarah.holmes@uc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 21, 2009
• Study Start: May 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

US (3)