Status:
COMPLETED
Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE
Lead Sponsor:
BioCryst Pharmaceuticals
Conditions:
Hereditary Angioedema
HAE
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I an...
Eligibility Criteria
Inclusion
- Key
- A clinical diagnosis of hereditary angioedema Type 1 or Type 2, defined as having a C1-INH functional level and a C4 level below the lower limit of the normal (LLN) reference range, as assessed during the Screening period.
- Subject weight of ≥ 40 kg
- Access to and ability to use one or more acute medications approved by the relevant competent authority for the treatment of acute attacks of HAE
- Subjects must be medically appropriate for on-demand treatment as the sole medicinal management for their HAE during the study.
- Subjects must have a specified number of investigator-confirmed attacks during the run-in period of a maximum of 56 days from the Screening visit.
- 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
- Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology
- Use of C1-INH within 14 days or use of androgens or tranexamic acid within 28 days prior to the Screening visit for prophylaxis of HAE attacks, or initiation of these drugs during the study
- Current participation in any other investigational drug study or received another investigational drug within 30 days of the Screening visit
- Prior enrollment in a BCX7353 study
Key Trial Info
Start Date :
February 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03485911
Start Date
February 6 2018
End Date
April 6 2022
Last Update
June 26 2023
Active Locations (47)
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1
Study center
Birmingham, Alabama, United States, 35209
2
Study center
Scottsdale, Arizona, United States, 85251
3
Study center
Little Rock, Arkansas, United States, 72205
4
Study Center
San Diego, California, United States, 92122