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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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.

Detailed Summary:
Sponsor: Shire

Current Primary Outcome:

• Proportion of attacks treated with successful outcome [ Time Frame: 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 [ Time Frame: 24 hours ]
  partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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 ]

Original Secondary Outcome: Same as current

Information By: Shire

Dates:
Date Received: February 16, 2012
Date Started: November 2003
Date Completion:
Last Updated: April 20, 2016
Last Verified: April 2016