NCT03472040
Completed
Phase 2
An Open-label Study to Evaluate the Long-term Safety of Daily Oral BCX7353 in Subjects With Type I and II Hereditary Angioedema
Overview
- Phase
- Phase 2
- Intervention
- BCX7353
- Conditions
- Hereditary Angioedema
- Sponsor
- BioCryst Pharmaceuticals
- Enrollment
- 387
- Locations
- 2
- Primary Endpoint
- Safety & Tolerability
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 Angioedema (HAE).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
BCX7353 150 mg once daily
Intervention: BCX7353
Outcomes
Primary Outcomes
Safety & Tolerability
Time Frame: Up to 96 weeks (US) / 216 weeks (Rest of World (ROW)).
The number and percentage of subjects with treatment-emergent adverse events.
Secondary Outcomes
- Incidence of Acute Attacks of Angioedema in Subjects During Treatment(Up to 96 weeks (US) / 216 weeks (ROW))
- The Durability of Response to Treatment(Up to 96 weeks (US) / 216 weeks (ROW))
- Patient Reported Quality of Life (QoL) During Treatment(Up to 96 weeks (US) / 216 weeks (ROW))
- Patient's Satisfaction With Medication During Long Term Administration of Berotralstat(Up to 96 weeks (US) / 216 weeks (ROW))
Study Sites (2)
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