A Long Term Safety Study of BCX7353 in Hereditary Angioedema

• Status: Active, not recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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 HAE.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioCryst Pharmaceuticals
• Treatments: Berotralstat

Criteria

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)