Status:
COMPLETED
Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema
Lead Sponsor:
BioCryst Pharmaceuticals
Conditions:
Hereditary Angioedema (HAE)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor, BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary angioedema (HAE). In each...
Eligibility Criteria
Inclusion
- Able to provide written, informed consent.
- A clinical diagnosis of hereditary angioedema Type 1 or Type 2 as documented at any time in the medical records or at the screening visit.
- Access to and ability to use standard of care acute attack treatment for attacks of HAE.
- Sexually active women of child-bearing potential and sexually active men must utilize effective contraception.
Exclusion
- Women who are pregnant or breast-feeding.
- Any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study.
- Use of C1INH, androgens or tranexamic acid for prophylaxis of HAE attacks.
- History of or current alcohol or drug abuse.
- Infection with hepatitis B, hepatitis C or HIV.
- Participation in any other investigational drug study currently or within the last 30 days.
- Positive drugs of abuse screen (unless as used as medical treatment, e.g., with a prescription).
- An immediate family relationship to either Sponsor employees, the Investigator or employees of the study site.
Key Trial Info
Start Date :
July 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2019
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03240133
Start Date
July 31 2017
End Date
January 29 2019
Last Update
April 1 2021
Active Locations (24)
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1
Study Center
Graz, Austria
2
Study Center
Odense, Denmark
3
Study Center
Grenoble, France
4
Study Center
Lille, France