A Long Term Safety Study of BCX7353 in Hereditary Angioedema
NCT03472040 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 387
Last updated 2023-06-18
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
- DRUG
-
BCX7353
BCX7353 mg oral capsules administered once daily
Sponsors & Collaborators
-
BioCryst Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Henriette Farkas, MD · Semmelweis University, Budapest, Hungary
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-16
- Primary Completion
- 2022-04-27
- Completion
- 2022-04-27
- FDA Drug
- Yes
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
Study Locations
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