Hereditary Angioedema (HAE)
Conditions
Brief summary
EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients with Hereditary Angioedema.
Interventions
DRUGDX-88 (ecallantide)
solution for injection 10 mg/mL
Sponsors
Shire
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 10 years of age or older * Documented diagnosis of HAE (Type I or II) * Patient reported to a study site no later than 4 hours following patient recognition of the onset of the attack * Willing and able to give informed consent
Exclusion criteria
* Patients with a serious intercurrent illness or serious active infection * Patient with serum creatinine greater than 110% the upper limit of normal or liver transaminases 2 times the upper limit of normal * Receipt of an investigational drug or device, within 30 days prior to study treatment * Pregnancy or breastfeeding * Diagnosis of acquired angioedema (AAE) * Patients who had not completed their Day-7 follow-up procedures for a previously treated attack
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of attacks treated with successful outcome | 24 hours | successful outcome is defined as attack resolution begun within 4 hrs after treatment and maintained for 24 hours |
| Proportion of attacks with a partial response | 24 hours | partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who respond to a 2nd dose of ecallantide after an initial, partial response | 24 hours |
| Time to resolution onset of each acute attack, as determined by patient report | 24 hours |
Outcome results
None listed