NCT02670720

Open-label, Long-term Safety Study of Avoralstat in Subjects With Hereditary Angioedema

OPuS-4: An Open-label Study to Evaluate the Long-term Safety of Avoralstat in Subjects With Hereditary Angioedema

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: BioCryst Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label study designed to evaluate the long-term safety of prophylactic avoralstat (500 mg three times daily) when given to approximately 150 patients with hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.

Conditions

• Hereditary Angioedema
• HAE

Interventions

Type	Name	Description
DRUG	avoralstat

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2016-02-02
• Last updated: 2016-02-17

Locations

3 sites across 2 countries: Belgium, France