An Open-label Study to Evaluate the Long-term Safety of Daily Oral BCX7353 in Subjects With Type I and II Hereditary Angioedema

BCX7353-204

This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE).

2018-02-16

2022-04-27

2022-04-27

Completed

Early phase I

387

Key Inclusion Criteria: * Subjects with HAE Type I or II who either have participated in a previous BCX7353 study or, in selected countries, in the opinion of the Investigator are expected to derive benefit from an oral treatment for the prevention of angioedema attacks. * Access to appropriate medication for treatment of acute attacks * Acceptable effective contraception * Written informed consent Key Exclusion Criteria: * Pregnancy or breast-feeding * 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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 387, 'type': 'ACTUAL'}}

2023-06-18