A Long Term Safety Study of BCX7353 in Hereditary Angioedema (APeX-S)

BioCryst

Status and phase

Completed

Phase 3

Phase 2

Conditions

HAE

Prophylaxis

Hereditary Angioedema

Treatments

Drug: BCX7353

Study type

Interventional

Funder types

Industry

Identifiers

NCT03472040

BCX7353-204

Details and patient eligibility

About

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 Hereditary Angioedema (HAE).

Enrollment

387 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)