Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 3b open-label study providing access to berotralstat for HAE patients who were previously enrolled in berotralstat studies.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioCryst Pharmaceuticals
• Treatments: Berotralstat

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.