Overview

Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
BioCryst Pharmaceuticals
Criteria
Key Inclusion Criteria:

- Written informed consent

- Clinical and laboratory diagnosis of Hereditary Angioedema Type I or II

- An average angioedema attack frequency of 1/week

- Acceptable birth control measures

Key Exclusion Criteria:

- Concurrent use of defined treatments for prophylaxis

- Pregnancy or breast-feeding

- Clinically significant medical condition, laboratory abnormality or medical history