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Kallikrein Inhibitor

Ecallantide in conjunction with Conventional Therapy for Angioedema (ACE Trial)

Phase 2
Waitlist Available
Led By Joseph Moellman, MD
Research Sponsored by Bernstein, Jonathan A., M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

ACE 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.

ACE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ACE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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.
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.

ACE Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Historical EvaluationActive Control1 Intervention
Group II: Ecallantide in conjunction with Conventional TherapyActive Control1 Intervention
Group III: Conventional therapy and placeboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Dyax Corp.Industry Sponsor
3 Previous Clinical Trials
157 Total Patients Enrolled
3 Trials studying Angioedema
157 Patients Enrolled for Angioedema
Bernstein, Jonathan A., M.D.Lead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
Joseph Moellman, MDPrincipal InvestigatorUC Physicians, Department of Emergency Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
2010. "Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01036659.
All > Hereditary Angioedema
~3 spots leftby Apr 2025
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