NCT03472040

A Long Term Safety Study of BCX7353 in Hereditary Angioedema

An Open-label Study to Evaluate the Long-term Safety of Daily Oral BCX7353 in Subjects With Type I and II Hereditary Angioedema

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: BioCryst Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE).

Conditions

• Hereditary Angioedema
• HAE
• Prophylaxis

Interventions

Type	Name	Description
DRUG	BCX7353	BCX7353 mg oral capsules administered once daily

Timeline

• Start date: 2018-02-16
• Primary completion: 2022-04-27
• Completion: 2022-04-27
• First posted: 2018-03-21
• Last updated: 2023-06-18
• Results posted: 2023-06-18

Locations

87 sites across 20 countries: United States, Australia, Austria, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, New Zealand, North Macedonia, Poland, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study