A Long Term Safety Study of BCX7353 in Hereditary Angioedema

  • STATUS
    Recruiting
  • End date
    Feb 15, 2024
  • participants needed
    475
  • sponsor
    BioCryst Pharmaceuticals
Updated on 15 October 2020
Investigator
Clinical Trials Coordinator
Primary Contact
Study Center (2.2 mi away) Contact
+92 other location
angioedema

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 HAE.

Details
Treatment BCX7353
Clinical Study IdentifierNCT03472040
SponsorBioCryst Pharmaceuticals
Last Modified on15 October 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 12 yrs?
Gender: Male or Female
Do you have any of these conditions: HEREDITARY ANGIOEDEMA or prevention & control?
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)
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Step 2 Get screened

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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