12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks
NCT ID: NCT02303626
Last Updated: 2025-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
110 participants
INTERVENTIONAL
2014-12-17
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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BCX4161 300 mg three times daily
Three BCX4161 capsules (100 mg) and two placebo capsules to be taken three times daily by mouth
BCX4161
Placebo
BCX4161 500 mg three times daily
Five BCX4161 capsules (100 mg) to be taken three times daily by mouth
BCX4161
Placebo three times daily
Five placebo capsules to be taken three times daily by mouth
Placebo
Interventions
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BCX4161
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Documented HAE attacks within a defined calendar period; in the absence of documented HAE attacks, participants will be required to enter a run-in period to document attacks
3. Access to acute attack medications
4. Sexually active women of child-bearing potential and sexually active men must utilize highly effective contraception
Exclusion Criteria
2. Any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study
3. Use of C1INH or tranexamic acid for prophylaxis of HAE attacks
4. Current participation in any other investigational drug study or within the last 30 days
5. History of or current alcohol or drug abuse
6. Infection with hepatitis B, hepatitis C or HIV
18 Years
ALL
No
Sponsors
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BioCryst Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Riedl, MD MS
Role: PRINCIPAL_INVESTIGATOR
UCSD
Locations
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Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Granada Hills, California, United States
San Diego, California, United States
San Diego, California, United States
Walnut Creek, California, United States
Colorado Springs, Colorado, United States
Shreveport, Louisiana, United States
Chevy Chase, Maryland, United States
Boston, Massachusetts, United States
Plymouth, Minnesota, United States
St Louis, Missouri, United States
New York, New York, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Lake Oswego, Oregon, United States
Hershey, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Galveston, Texas, United States
Fairfax, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Leuven, , Belgium
Ottawa, , Canada
Grenoble, , France
Lille, , France
Paris, , France
Berlin, , Germany
Frankfurt, , Germany
Mörfelden-Walldorf, , Germany
Budapest, , Hungary
Milan, , Italy
Birmingham, , United Kingdom
Bristol, , United Kingdom
Cardiff, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
Other Identifiers
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BCX4161-301
Identifier Type: -
Identifier Source: org_study_id
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