Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-26 @ 7:28 PM
Study NCT ID:
NCT04428632
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2020-12-11
First Post:
2020-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Berotralstat Expanded Access Program
Sponsor:
BioCryst Pharmaceuticals
Organization:
Study Overview
Official Title:
Expanded Access Program With Oral Berotralstat for the Prevention of Attacks in Patients With Hereditary Angioedema
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 be interested should contact their physician about participation
Berotralstat (BCX7353) will be available through this expanded access program until it is commercially available
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: