NL-OMON48865
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 - A long term study of BCX7353 in the prevention of HAE attacks
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- BioCryst Pharmaceuticals Inc.
- Enrollment
- 3
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males and nonpregnant, nonlactating females \>\=18 years of age (main study) ;
- •2\. Subjects with Type I or II HAE who have either participated in a BCX7353
- •efficacy study OR
- •expected to derive benefit from oral treatment for the prevention of angioedema
- •attacks and have a clinical diagnosis of HAE Type 1 or Type2, defined as C1\-INH
- •functional level below 50% and C4 level below lower limit of normal OR a known
- •SERPING\-1 gene mutation known or likely to be associated with HAE Type 1 or 2
- •OR confirmed family history OR low C4 value from a sample drawn during a HAE
- •3\. Subject weight \>\= 40kg
- •4\. Access to appropriate medication for the treatment of acute HAE attacks
Exclusion Criteria
- •1\. Pregnancy or breast feeding or planned pregnancy during the study period
- •2\. 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
- •3\. Discontinuation of study drug due to a hypersensitivity reaction to BCX7353
- •in a prior study. This includes subjects who had a rash of any severity
- •identified as possibly, probably, or definitely related to active BCX7353 in
- •the previous study
- •4\. Dementia, altered mental status or any psychiatric condition, that would
- •prohibit the understanding or rendering of informed consent or participation in
Outcomes
Primary Outcomes
Not specified
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