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Clinical trial

An Open-label Study to Provide Berotralstat Access to Subjects With Type 1 and 2 Hereditary Angioedema Who Were Previously Enrolled in Berotralstat Studies

ID
Name
BCX7353-312
Description
This is a phase 3b open-label study providing access to berotralstat for HAE patients who were previously enrolled in berotralstat studies.
Trial arms
Trial start
2021-07-23
Estimated PCD
2026-08-01
Trial end
2026-08-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
berotralstat
BCX7353 capsules administered orally once daily
Arms:
BCX7353 Capsules 150 mg once daily
Other names:
Orladeyo
Size
110
Primary endpoint
Number and proportion of subjects with a treatment-related TEAE
240 weeks
Number and proportion of subjects who experience a serious adverse event (SAE)
240 weeks
Number and proportion of subjects who experience a treatment-related Grade 3 or 4 TEAE
240 weeks
Number and proportion of subjects who experience a treatment-related Grade 3 or 4 treatment-emergent chemistry abnormality
240 weeks
Number and proportion of subjects who discontinue due to a TEAE
240 weeks
Eligibility criteria
Key Inclusion Criteria: * Males and females currently enrolled in BioCryst-sponsored Study 302 or 204 * Able to provide written informed consent. * Would benefit from continued berotralstat treatment * Acceptable effective contraception Key Exclusion Criteria: * Pregnancy or breast-feeding * Any condition or situation, including 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 * Use of other medications for long-term prophylaxis of HAE attacks at the Baseline visit or any time during the study. * Use of any other investigational medicinal product at the Baseline visit or any time during the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label berotralstat (BCX7353) 150 mg orally administered QD.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking as this is open-label.'}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}
Updated at
2023-05-18

1 organization

1 product

1 indication

Organization
BioCryst Pharmaceuticals
Product
berotralstat
Indication
Hereditary Angioedema