Angioedema
Conditions
Keywords
acute angiotensin converting enzyme inhibitor angioedema
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.
Interventions
DRUGecallantide - 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.
Sponsors
Dyax Corp.
Bernstein, Jonathan A., M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactJillian Picard, RN
Backup ContactSarah J. Holmes, RN
Outcome results
None listed