A Long Term Safety Study of BCX7353 in Hereditary Angioedema (NCT03472040) | Clinical Trial Compass
CompletedPhase 2/3
A Long Term Safety Study of BCX7353 in Hereditary Angioedema
United States387 participantsStarted 2018-02-16
Plain-language 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).
Who can participate
Age range12 Years
SexALL
See this in plain English?
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Key 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
Key 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)
What they're measuring
1
Safety & Tolerability
Timeframe: Up to 96 weeks (US) / 216 weeks (Rest of World (ROW)).