Open-label, Long-term Safety Study of Avoralstat in Subjects With Hereditary Angioedema

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label study designed to evaluate the long-term safety of prophylactic avoralstat (500 mg three times daily) when given to approximately 150 patients with hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.

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

Details

• Lead Sponsor: BioCryst Pharmaceuticals

Criteria

Inclusion Criteria:

• Males and non-pregnant, non-lactating females age ≥ 18 years.

• Provide written, informed consent.

• Prior completion of an avoralstat therapeutic study OR a confirmed diagnosis of HAE Type 1 or HAE Type 2.

• Access to appropriate medication for the treatment of acute HAE attacks.

• Adequate contraception.

Exclusion Criteria:

• Females who are pregnant or breast feeding.

• Clinically significant medical condition or medical history.

• Abnormal screening ECG, laboratory or urinalysis finding that is clinically significant.

• Investigational drug exposure within 30 days (except avoralstat).

• History of or current alcohol or drug abuse.

• HIV or active HBV or HCV infection.