Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan
NCT ID: NCT03873116
Last Updated: 2024-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
19 participants
INTERVENTIONAL
2018-12-27
2021-07-08
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
TRIPLE
Study Groups
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BCX7353 110mg once daily
BCX7353 capsules administered orally once daily
BCX7353 capsules
BCX7353 capsules administered orally once daily
BCX7353 150mg once daily
BCX7353 capsules administered orally once daily
BCX7353 capsules
BCX7353 capsules administered orally once daily
Placebo
Matching placebo oral capsules administered orally once daily
Placebo oral capsule
Matching placebo capsules administered orally once daily
Interventions
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BCX7353 capsules
BCX7353 capsules administered orally once daily
BCX7353 capsules
BCX7353 capsules administered orally once daily
Placebo oral capsule
Matching placebo capsules administered orally once daily
Eligibility Criteria
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Inclusion Criteria
* Access to and ability to use one or more acute medications approved by the relevant competent authority for the treatment of acute attacks of HAE
* Subjects must be medically appropriate for on-demand treatment as the sole medicinal management for their HAE during the study.
* Subjects must have a specified number of expert-confirmed attacks during the run-in period of 56 days from the Screening visit.
* 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
* Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology
* Use of C1-INH within 14 days or use of androgens or tranexamic acid within 28 days prior to the Screening visit for prophylaxis of HAE attacks, or initiation of these drugs during the study
* Current participation in any other investigational drug study or received another investigational drug within 30 days of the Screening visit
* Prior enrollment in a BCX7353 study
12 Years
ALL
No
Sponsors
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BioCryst Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Isao Ohsawa
Role: PRINCIPAL_INVESTIGATOR
Saiyu Soka Hospital
Locations
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Study Site
Chiba, , Japan
Study Site
Gunma, , Japan
Study Site
Hokkaido, , Japan
Study Site
Nagoya, , Japan
Study Site
Osaka, , Japan
Study Center
Saga, , Japan
Study Site
Saitama, , Japan
Study Site
Shimane, , Japan
Study Site
Shizuoka, , Japan
Study Site
Tokyo, , Japan
Countries
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References
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Honda D, Hide M, Fukuda T, Koga K, Morita E, Moriwaki S, Sasaki Y, Suzuki Y, Collis P, Johnston DT, Tomita D, Desai B, Ohsawa I. Berotralstat for long-term prophylaxis of hereditary angioedema in Japan: Parts 2 and 3 of the randomized APeX-J Phase III trial. World Allergy Organ J. 2024 Mar 2;17(3):100882. doi: 10.1016/j.waojou.2024.100882. eCollection 2024 Mar.
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.
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.
Ohsawa I, Honda D, Suzuki Y, Fukuda T, Kohga K, Morita E, Moriwaki S, Ishikawa O, Sasaki Y, Tago M, Chittick G, Cornpropst M, Murray SC, Dobo SM, Nagy E, Van Dyke S, Reese L, Best JM, Iocca H, Collis P, Sheridan WP, Hide M. Oral berotralstat for the prophylaxis of hereditary angioedema attacks in patients in Japan: A phase 3 randomized trial. Allergy. 2021 Jun;76(6):1789-1799. doi: 10.1111/all.14670. Epub 2020 Dec 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BCX7353-301
Identifier Type: -
Identifier Source: org_study_id
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