NCT02586805

Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
DRUG	DX-2930 - 300mg/2wk	300 mg DX-2930 administered every 2 weeks by subcutaneous injection.
DRUG	DX-2930 - 300mg/4wk	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.
DRUG	DX-2930 - 150mg/4wk	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.
DRUG	Placebo	Placebo administered every 2 weeks by subcutaneous injection.

Timeline

• Start date: 2016-03-03
• Primary completion: 2017-04-13
• Completion: 2017-04-13
• First posted: 2015-10-26
• Last updated: 2021-06-02
• Results posted: 2018-04-24

Locations

41 sites across 7 countries: United States, Canada, Germany, Italy, Jordan, Puerto Rico, United Kingdom