Status:
COMPLETED
12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks
Lead Sponsor:
BioCryst Pharmaceuticals
Conditions:
Hereditary Angioedema
HAE
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in participants with hereditary angioedema (HAE). Eligible participants will be randomized t...
Eligibility Criteria
Inclusion
- Key
- A clinical diagnosis of HAE type I or II
- Documented HAE attacks within a defined calendar period; in the absence of documented HAE attacks, participants will be required to enter a run-in period to document attacks
- Access to acute attack medications
- Sexually active women of child-bearing potential and sexually active men must utilize highly effective contraception
- Key
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 or tranexamic acid for prophylaxis of HAE attacks
- Current participation in any other investigational drug study or within the last 30 days
- History of or current alcohol or drug abuse
- Infection with hepatitis B, hepatitis C or HIV
Key Trial Info
Start Date :
December 17 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02303626
Start Date
December 17 2014
End Date
January 1 2016
Last Update
November 17 2025
Active Locations (40)
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1
Birmingham, Alabama, United States, 35209
2
Scottsdale, Arizona, United States, 85251
3
Granada Hills, California, United States, 91344
4
San Diego, California, United States, 92093