Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies
Sponsored by BioCryst Pharmaceuticals
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 4 years ago
What is this trial about?
What are the Participation Requirements?
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.