Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema
NCT ID: NCT02870972
Last Updated: 2021-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2016-08-31
2017-08-31
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
DOUBLE
Study Groups
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Part 1: BCX7353 350 mg once daily
BCX7353 capsules, 350 mg dose administered once per day for 28 days
BCX7353
Plasma kallikrein inhibitor
Parts 2 and 3: BCX7353 250 mg once daily
BCX7353 capsules, 250 mg dose administered once per day for 28 days
BCX7353
Plasma kallikrein inhibitor
Parts 2 and 3: BCX7353 125 mg once daily
BCX7353 capsules, 125 mg dose administered once per day for 28 days
BCX7353
Plasma kallikrein inhibitor
Parts 1, 2 and 3: Placebo
Placebo capsules, administered once per day for 28 days
Placebo
Part 3: BCX7353 62.5 mg once daily
BCX7353 capsules, 62.5 mg dose administered once per day for 28 days
BCX7353
Plasma kallikrein inhibitor
Interventions
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BCX7353
Plasma kallikrein inhibitor
Placebo
Eligibility Criteria
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Inclusion Criteria
* Documented HAE attacks within a defined calendar period
* Access to acute attack medications
* Sexually active women of child-bearing potential and sexually active men must utilize effective contraception
Exclusion Criteria
* Any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study
* Use of C1INH, androgens or tranexamic acid for prophylaxis of HAE attacks
* History of or current alcohol or drug abuse
* Infection with hepatitis B, hepatitis C or HIV
* Participation in any other investigational drug study currently or within the last 30 days
18 Years
70 Years
ALL
No
Sponsors
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BioCryst Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Emel Aygören-Pürsün, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Frankfurt Goethe University
Locations
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Adelaide, , Australia
Campbelltown, , Australia
Graz, , Austria
Vienna, , Austria
Québec, , Canada
Toronto, , Canada
Odense, , Denmark
Berlin, , Germany
Frankfurt, , Germany
Ulm, , Germany
Budapest, , Hungary
Milan, , Italy
Padua, , Italy
Salerno, , Italy
Skopje, , North Macedonia
Barcelona, , Spain
Madrid, , Spain
Seville, , Spain
Zurich, , Switzerland
Brimingham, , United Kingdom
Bristol, , United Kingdom
London, , United Kingdom
Oxford, , United Kingdom
Southampton, , United Kingdom
Countries
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References
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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.
Aygoren-Pursun E, Bygum A, Grivcheva-Panovska V, Magerl M, Graff J, Steiner UC, Fain O, Huissoon A, Kinaciyan T, Farkas H, Lleonart R, Longhurst HJ, Rae W, Triggiani M, Aberer W, Cancian M, Zanichelli A, Smith WB, Baeza ML, Du-Thanh A, Gompels M, Gonzalez-Quevedo T, Greve J, Guilarte M, Katelaris C, Dobo S, Cornpropst M, Clemons D, Fang L, Collis P, Sheridan W, Maurer M, Cicardi M. Oral Plasma Kallikrein Inhibitor for Prophylaxis in Hereditary Angioedema. N Engl J Med. 2018 Jul 26;379(4):352-362. doi: 10.1056/NEJMoa1716995.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BCX7353-203
Identifier Type: -
Identifier Source: org_study_id
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