Trials / Completed
CompletedNCT03485911
Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects With Hereditary Angioedema
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- BioCryst Pharmaceuticals · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BCX7353 capsules | BCX7353 oral capsules administered once daily |
| DRUG | Placebo oral capsule | Matching oral capsules administered once daily |
Timeline
- Start date
- 2018-02-06
- Primary completion
- 2019-04-10
- Completion
- 2022-04-06
- First posted
- 2018-04-03
- Last updated
- 2023-06-26
- Results posted
- 2021-03-02
Locations
47 sites across 11 countries: United States, Austria, Canada, Czechia, France, Germany, Hungary, North Macedonia, Romania, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03485911. Inclusion in this directory is not an endorsement.