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

EDEMA2: An Open-Label Study to Assess the Efficacy and Tolerability of Repeated Doses of DX-88 (Recombinant Plasma Kallikrein Inhibitor) in Patients With Hereditary Angioedema

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.

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