Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BioCryst Pharmaceuticals
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A clinical diagnosis of hereditary angioedema Type 1 or Type 2, defined as having a C1-INH functional level and a C4 level below the lower limit of the normal (LLN) reference range, as assessed during the Screening period.
Subject weight of ≥ 40 kg
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 investigator-confirmed attacks during the run-in period of a maximum of 56 days from the Screening visit.
Acceptable effective contraception
Written informed consent
You may not be if
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
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
Clareo Health | Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE
