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

Angioedema Clinical Trial

— ACE  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01036659
• Other study ID #: ACE Induced Angioedema
• Status: Unknown status
• Phase: Phase 2
• First received: December 18, 2009
• Last updated: March 8, 2012
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2012
• Source: Bernstein, Jonathan A., M.D.
• Contact: Jillian Picard, RN
• Phone: 513-558-0924
• Email: jillian.picard[@]uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angioedema

Intervention

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.

Locations

Country	Name	City	State
United States	The Jewish Hospital	Cincinnati	Ohio
United States	UC Physicians, Dpt of Internal Medicine, Division of Immunology	Cincinnati	Ohio
United States	Univeristy Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Bernstein, Jonathan A., M.D.	Dyax Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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