EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema

Shire77 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hereditary Angioedema (HAE)

Interventions

DX-88 (ecallantide)DRUG

solution for injection 10 mg/mL

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of attacks treated with successful outcome

successful outcome is defined as attack resolution begun within 4 hrs after treatment and maintained for 24 hours

Time frame: 24 hours

Proportion of attacks with a partial response

partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours

Time frame: 24 hours

Secondary Outcomes

Proportion of patients who respond to a 2nd dose of ecallantide after an initial, partial response

Time frame: 24 hours

Time to resolution onset of each acute attack, as determined by patient report

Time frame: 24 hours

Data from ClinicalTrials.gov

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