Oral Berotralstat Expanded Access Program

N/AApproved For MarketingNCT04428632

BioCryst Pharmaceuticals

Overview

This expanded access program will provide access to berotralstat for eligible participants with hereditary angioedema in the U.S.

Physicians may request access to berotralstat for eligible participants with unmet medical need Physicians can send email inquiries to access.us@inceptua.com or call 1-888-225-8677 Patients who may be interested should contact their physician about participation Berotralstat (BCX7353) will be available through this expanded access program until it is commercially available

Study Type

EXPANDED_ACCESS

Conditions

Hereditary Angioedema HAE Prophylaxis

Interventions

BerotralstatDRUG

One 150mg capsule administered orally once daily

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients must meet all of the following inclusion criteria to be eligible for participation in this program: 1. At least 12 years of age 2. Able to provide written, informed consent or assent 3. Patients with a clinical diagnosis of HAE Type I or II who, in the opinion of their treating physician, are expected to benefit from an oral treatment for the prevention of angioedema attacks, and who are not eligible or able to access a berotralstat clinical trial 4. Females must use acceptable effective contraception Exclusion Criteria Patients must meet none of the below exclusion criteria to be eligible for participation in this program: 1. Pregnancy or breast-feeding 2. Any clinically significant medical condition or medical history that, in the opinion of the treating physician, would interfere with the patient's safety 3. Current infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.