Status:
COMPLETED
A Long Term Safety Study of BCX7353 in Hereditary Angioedema
Lead Sponsor:
BioCryst Pharmaceuticals
Conditions:
Hereditary Angioedema
HAE
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angi...
Eligibility Criteria
Inclusion
- Key
- Subjects with HAE Type I or II who either have participated in a previous BCX7353 study or, in selected countries, in the opinion of the Investigator are expected to derive benefit from an oral treatment for the prevention of angioedema attacks.
- Access to appropriate medication for treatment of acute attacks
- Acceptable effective contraception
- Written informed consent
- Key
Exclusion
- Pregnancy or breast-feeding
- Any clinically significant medical condition or medical history that, in the opinion of the Investigator or Sponsor, would interfere with the subject's safety or ability to participate in the study
- Any laboratory parameter abnormality that, in the opinion of the Investigator, is clinically significant and relevant for this study
- Discontinuation of study drug due to a hypersensitivity reaction BCX7353 in a prior study
- Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology
- Unacceptable noncompliance in a previous BCX7353 study (if applicable) as assessed by the Sponsor or Investigator
- Investigational drug exposure, other than BCX7353, within 30 days prior to the screening visit (or baseline if no screening visit)
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2022
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT03472040
Start Date
February 16 2018
End Date
April 27 2022
Last Update
June 18 2023
Active Locations (87)
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1
Study Center
Birmingham, Alabama, United States, 35209
2
Study Center
Scottsdale, Arizona, United States, 85251
3
Study Center
Bentonville, Arkansas, United States, 72712
4
Study Center
Little Rock, Arkansas, United States, 72205