At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Angioedema (HAE)
In Brief
A Phase 3 clinical trial evaluating DX-2930 - 300mg/2wk, DX-2930 - 300mg/4wk, and 2 other interventions for Hereditary Angioedema (HAE). Completed, enrolled 125 participants across 41 sites in 7 countries.
Detailed Summary
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
Study Details
Timeline
Interventions
300 mg DX-2930 administered every 2 weeks by subcutaneous injection.
300 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.
150 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.
Placebo administered every 2 weeks by subcutaneous injection.