NCT02741596

Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE

HELP Study ExtensionTM: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of DX-2930 for Prevention Against Acute Attacks of Hereditary Angioedema (HAE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, long term safety and efficacy study to evaluate DX-2930 in preventing acute angioedema attacks in participants with Type I and Type II HAE.

Conditions

• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
DRUG	DX-2930	Participants who rollover from the DX-2930-03 study will receive 300 milligram (mg) DX-2930 subcutaneous injection at Day 0 followed by second dose following the first HAE attack and then once in every 2 weeks until the end of the treatment period (up to 924 days). A wash-out period of a minimum of 10 days and a maximum of 18 days is required between subsequent administrations.
DRUG	DX-2930	Participants who were not participants in DX-2930-03 will receive 300 milligram (mg) DX-2930 subcutaneous injection once in every 2 weeks until the end of the treatment period (up to 924 days).

Timeline

• Start date: 2016-05-26
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2016-04-18
• Last updated: 2021-06-08
• Results posted: 2020-05-11

Locations

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

Regulatory

• FDA-regulated drug study