Trials / Completed
CompletedNCT03873116
Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan
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
- 19 (actual)
- Sponsor
- BioCryst Pharmaceuticals · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 3, multi-center, 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 who live in Japan.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BCX7353 capsules | BCX7353 capsules administered orally once daily |
| DRUG | BCX7353 capsules | BCX7353 capsules administered orally once daily |
| DRUG | Placebo oral capsule | Matching placebo capsules administered orally once daily |
Timeline
- Start date
- 2018-12-27
- Primary completion
- 2021-07-08
- Completion
- 2021-07-08
- First posted
- 2019-03-13
- Last updated
- 2024-07-19
- Results posted
- 2021-03-04
Locations
10 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03873116. Inclusion in this directory is not an endorsement.