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

  • 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 0 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 0 through Day 182) ]
  • Number of Investigator confirmed HAE attacks for each DX-2930 treatment arm versus placebo arm occurring on Day 14 through Day 182 [ Time Frame: Day 14 through Day 182 ]


    • 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