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NCT03485911 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE
A Phase 3 study, sponsored by BioCryst Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 121
- Enrollment target
NCT03485911: Completed Phase 3 study, sponsored by BioCryst Pharmaceuticals.
NCT03485911 is a Phase 3 study that has completed, run by BioCryst Pharmaceuticals. The registered enrollment target is 121 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03485911, a Phase 3 study, has completed, sponsored by BioCryst Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 121 participants
- Enrollment target
Study 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.
Primary Outcome
Treatment comparisons between each berotralstat dose and placebo in the rate of investigator-confirmed HAE attacks during the Part 1 dosing period were analyzed using a negative binomial model. The number of investigator-confirmed attacks was included as the dependent variable, the treatment was included as a fixed effect, the stratification variable (baseline attack rate) was included as a covariate, and the logarithm of duration on treatment was included as an offset variable. The estimated at
Interventions
- DRUG Placebo oral capsule
- DRUG BCX7353 capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2018-02-06 |
| Est. Completion | 2022-04-06 |
| Phase | Phase 3 |
What the finished NCT03485911 record still lists
NCT03485911 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03485911 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03485911 about?
NCT03485911 is a clinical study titled "Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE". 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.
What is the current status of trial NCT03485911?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 121 participants. The study started on 2018-02-06. Estimated completion is 2022-04-06.
What interventions are being tested in trial NCT03485911?
The interventions under investigation include: Placebo oral capsule (DRUG), BCX7353 capsules (DRUG).
Who is sponsoring clinical trial NCT03485911?
This trial is sponsored by BioCryst Pharmaceuticals, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03485911's enrollment target sits among peer trials
121 1619th of 2000 higher than 382 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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