Clinical trialNCT02303626CompletedPhase 2/PHASE3Interventional

12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks

SponsorBioCryst PharmaceuticalsEnrollment110HAEHereditary Angioedema

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in participants with hereditary angioedema (HAE). Eligible participants will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to placebo.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Marc Riedl, MD MS
UCSD
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

40 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Belgium

Facility name not stated
Leuven, Belgium

Canada

Facility name not stated
Ottawa, Canada

France

Facility name not stated
Grenoble, France
Facility name not stated
Lille, France
Facility name not stated
Paris, France

Germany

Facility name not stated
Berlin, Germany
Facility name not stated
Frankfurt, Germany
Facility name not stated
Mörfelden-Walldorf, Germany

Hungary

Facility name not stated
Budapest, Hungary

Italy

Facility name not stated
Milan, Italy

United Kingdom

Facility name not stated
Birmingham, United Kingdom
Facility name not stated
Bristol, United Kingdom
Facility name not stated
Cardiff, United Kingdom
Facility name not stated
London, United Kingdom
Facility name not stated
Manchester, United Kingdom

United States

Facility name not stated
Birmingham, Alabama, United States
Facility name not stated
Scottsdale, Arizona, United States
Facility name not stated
Granada Hills, California, United States
Facility name not stated
San Diego, California, United States
Facility name not stated
San Diego, California, United States
Facility name not stated
Walnut Creek, California, United States
Facility name not stated
Colorado Springs, Colorado, United States
Facility name not stated
Shreveport, Louisiana, United States
Facility name not stated
Chevy Chase, Maryland, United States
Facility name not stated
Boston, Massachusetts, United States
Facility name not stated
Plymouth, Minnesota, United States
Facility name not stated
St Louis, Missouri, United States
Facility name not stated
New York, New York, United States
Facility name not stated
Charlotte, North Carolina, United States
Facility name not stated
Cincinnati, Ohio, United States
Facility name not stated
Oklahoma City, Oklahoma, United States
Facility name not stated
Tulsa, Oklahoma, United States
Facility name not stated
Lake Oswego, Oregon, United States
Facility name not stated
Hershey, Pennsylvania, United States
Facility name not stated
Pittsburgh, Pennsylvania, United States
Facility name not stated
Dallas, Texas, United States
Facility name not stated
Galveston, Texas, United States
Facility name not stated
Fairfax, Virginia, United States
Facility name not stated
Spokane, Washington, United States
Facility name not stated
Tacoma, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

BCX4161Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 17 Dec 2014
Primary completion: 31 Jan 2016
Completion: 31 Jan 2016
Last update posted: 17 Nov 2025
Registered enrollment: 110
Registry id: NCT02303626

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.