Last updated on November 2019
A Long Term Safety Study of BCX7353 in Hereditary Angioedema
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: prevention & control | HEREDITARY ANGIOEDEMA
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Age: Between 12 - 100 Years
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Gender: Male or Female
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)