Status:
APPROVED_FOR_MARKETING
Oral Berotralstat Expanded Access Program
Lead Sponsor:
BioCryst Pharmaceuticals
Conditions:
Hereditary Angioedema
HAE
Eligibility:
All Genders
12+ years
Brief Summary
This expanded access program will provide access to berotralstat for eligible participants with hereditary angioedema in the U.S.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients must meet all of the following inclusion criteria to be eligible for participation in this program:
- At least 12 years of age
- Able to provide written, informed consent or assent
- 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
- 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:
- Pregnancy or breast-feeding
- Any clinically significant medical condition or medical history that, in the opinion of the treating physician, would interfere with the patient's safety
- Current infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04428632
Last Update
December 11 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.