A Long Term Safety Study of BCX7353 in Hereditary Angioedema
NCT ID: NCT03472040
Last Updated: 2023-06-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
387 participants
INTERVENTIONAL
2018-02-16
2022-04-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema
NCT02870972
Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE
NCT03485911
Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema
NCT03240133
Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE
NCT01984788
12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks
NCT02303626
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BCX7353 150 mg once daily
BCX7353
BCX7353 mg oral capsules administered once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BCX7353
BCX7353 mg oral capsules administered once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Access to appropriate medication for treatment of acute attacks
* Acceptable effective contraception
* Written informed consent
Exclusion Criteria
* Any clinically significant medical condition or medical history that, in the opinion of the Investigator or Sponsor, would interfere with the subject's safety or ability to participate in the study
* Any laboratory parameter abnormality that, in the opinion of the Investigator, is clinically significant and relevant for this study
* Discontinuation of study drug due to a hypersensitivity reaction BCX7353 in a prior study
* Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology
* Unacceptable noncompliance in a previous BCX7353 study (if applicable) as assessed by the Sponsor or Investigator
* Investigational drug exposure, other than BCX7353, within 30 days prior to the screening visit (or baseline if no screening visit)
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BioCryst Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Henriette Farkas, MD
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University, Budapest, Hungary
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Study Center
Birmingham, Alabama, United States
Study Center
Scottsdale, Arizona, United States
Study Center
Bentonville, Arkansas, United States
Study Center
Little Rock, Arkansas, United States
Study Center
San Diego, California, United States
Study Center
Walnut Creek, California, United States
Study Center
Centennial, Colorado, United States
Study Center
Colorado Springs, Colorado, United States
Study Center
Wheat Ridge, Colorado, United States
Study Center
Waterbury, Connecticut, United States
Study Center
Tampa, Florida, United States
Study Center
Marietta, Georgia, United States
Study Center
Normal, Illinois, United States
Study Center
Evansville, Indiana, United States
Study Center
Indianapolis, Indiana, United States
Study Center
Overland Park, Kansas, United States
Study Center
Louisville, Kentucky, United States
Study Center
Chevy Chase, Maryland, United States
Study Center
Boston, Massachusetts, United States
Study Center
Ann Arbor, Michigan, United States
Study Center
Grand Rapids, Michigan, United States
Study Center
Rochester, Minnesota, United States
Study Center
Madison, Mississippi, United States
Study Center
St Louis, Missouri, United States
Study Center
Lincoln, Nebraska, United States
Study Center
Charlotte, North Carolina, United States
Study Center
Durham, North Carolina, United States
Study Center
Cincinnati, Ohio, United States
Study Center
Columbus, Ohio, United States
Study Center
Clackamas, Oregon, United States
Study Center
Happy Valley, Oregon, United States
Study Center
Hershey, Pennsylvania, United States
Study Center
East Providence, Rhode Island, United States
Study Center
Greer, South Carolina, United States
Study Center
Austin, Texas, United States
Study Center
Dallas, Texas, United States
Study Center
Irving, Texas, United States
Study Center
San Antonio, Texas, United States
Study Center
Murray, Utah, United States
Study Center
Seattle, Washington, United States
Study Center
Spokane, Washington, United States
Study Center
Milwaukee, Wisconsin, United States
Study Center
Adelaide, , Australia
Study Center
Campbelltown, , Australia
Study Center
Camperdown, , Australia
Study Center
Melbourne, , Australia
Study Center
Murdoch, , Australia
Study Center
Nedlands, , Australia
Study Center
Graz, , Austria
Study Center
Vienna, , Austria
Study Center
Odense, , Denmark
Study Center
Grenoble, , France
Study Center
Lille, , France
Study Center
Paris, , France
Study Center
Berlin, , Germany
Study Center
Frankfurt, , Germany
Study Center
Ulm, , Germany
Study Center
Central, , Hong Kong
Study Center
Budapest, , Hungary
Study Center
Ashkelon, , Israel
Study Center
Haifa, , Israel
Study Center
Tel Aviv, , Israel
Study Center
Tel Litwinsky, , Israel
Study Center
Milan, , Italy
Study Center
Padua, , Italy
Study Center
Salerno, , Italy
Study Center
Auckland, , New Zealand
Study Center
Wellington, , New Zealand
Study Center
Skopje, , North Macedonia
Study Center
Krakow, , Poland
Study Center
Belgrade, , Serbia
Study Center
Niš, , Serbia
Study Center
Martin, , Slovakia
Study Center
Cape Town, , South Africa
Study Center
Daegu, , South Korea
Study Center
Donggu, , South Korea
Study Center
Gyeonggi-do, , South Korea
Study Center
Seoul, , South Korea
Study Center
Barcelona, , Spain
Study Center
Madrid, , Spain
Study Center
Zurich, , Switzerland
Study center
Birmingham, , United Kingdom
Study Center
Bristol, , United Kingdom
Study Center
Cambridge, , United Kingdom
Study Center
London, , United Kingdom
Study Center
Plymouth, , United Kingdom
Study Center
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Farkas H, Peter JG, Stobiecki M, Anderson J, Aygoren-Pursun E, Hagin D, Jesenak M, Kessel A, Kiani-Alikhan S, Kinaciyan T, Manning M, Reshef A, Wu A, Iocca HA, Johnston DT, Noble L, Tomita D, Banerji A. Long-term safety and efficacy of once-daily berotralstat in patients with hereditary angioedema: APeX-S final results. Ann Allergy Asthma Immunol. 2025 Sep;135(3):311-319.e6. doi: 10.1016/j.anai.2025.06.004. Epub 2025 Jun 7.
Peter JG, Desai B, Tomita D, Collis P, Stobiecki M. Assessment of HAE prophylaxis transition from androgen therapy to berotralstat: A subset analysis of the APeX-S trial. World Allergy Organ J. 2023 Nov 6;16(11):100841. doi: 10.1016/j.waojou.2023.100841. eCollection 2023 Nov.
Riedl MA, Soteres D, Sublett JW, Desai B, Tomita D, Collis P, Bernstein JA; APeX-S Study Investigators. Hereditary angioedema outcomes in US patients switched from injectable long-term prophylactic medication to oral berotralstat. Ann Allergy Asthma Immunol. 2024 Apr;132(4):505-511.e1. doi: 10.1016/j.anai.2023.11.016. Epub 2023 Nov 24.
Farkas H, Balla Z. A review of berotralstat for the treatment of hereditary angioedema. Expert Rev Clin Immunol. 2023 Feb;19(2):145-153. doi: 10.1080/1744666X.2023.2150611. Epub 2022 Nov 29.
Riedl MA, Neville D, Cloud B, Desai B, Bernstein JA. Shared decision-making in the management of hereditary angioedema: An analysis of patient and physician perspectives. Allergy Asthma Proc. 2022 Sep 1;43(5):397-405. doi: 10.2500/aap.2022.43.220050. Epub 2022 Jul 12.
Farkas H, Stobiecki M, Peter J, Kinaciyan T, Maurer M, Aygoren-Pursun E, Kiani-Alikhan S, Wu A, Reshef A, Bygum A, Fain O, Hagin D, Huissoon A, Jesenak M, Lindsay K, Panovska VG, Steiner UC, Zubrinich C, Best JM, Cornpropst M, Dix D, Dobo SM, Iocca HA, Desai B, Murray SC, Nagy E, Sheridan WP. Long-term safety and effectiveness of berotralstat for hereditary angioedema: The open-label APeX-S study. Clin Transl Allergy. 2021 Jun;11(4):e12035. doi: 10.1002/clt2.12035.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BCX7353-204
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.