Clinical Trial: Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: HELP Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate DX-2930 For Long-Term Prophylaxis Against Acute Attacks of Hereditary
Original Secondary Outcome:
- Time to first HAE attack for each DX-2930 treatment arm versus placebo arm [ Time Frame: Efficacy assessment period (Day 14 through Day 182) ]
- Number per week of HAE attacks requiring acute attack therapy use for each DX-2930 treatment arm versus placebo arm [ Time Frame: Efficacy assessment period (Day 14 through Day 182) ]
- Number per week of moderate or severe HAE attacks for each DX-2930 treatment arm versus placebo arm [ Time Frame: Efficacy assessment period (Day 14 through Day 182) ]
- Reduction in high-morbidity HAE attacks for each DX-2930 treatment arm versus placebo arm [ Time Frame: Efficacy assessment period (Day 14 through Day 182) ]A high-morbidity HAE attack is defined as any attack that has at least one of the following characteristics: severe, results in hospitalization (except hospitalization for observation <24 hours), hemodynamically significant (systolic blood pressure < 90, requires IV hydration, or associated with syncope or near-syncope) or laryngeal.
Information By: Shire
Dates:
Date Received: October 23, 2015
Date Started: November 2015
Date Completion:
Last Updated: May 23, 2017
Last Verified: May 2017