Open-label, Long-term Safety Study of Avoralstat in Subjects With Hereditary Angioedema (OPuS-4)

BioCryst

Status and phase

Terminated

Phase 3

Conditions

HAE

Hereditary Angioedema

Treatments

Drug: avoralstat

Study type

Interventional

Funder types

Industry

Identifiers

NCT02670720

BCX4161-303

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.