An open-label study to provide berotralstat access to subjects with type I and II hereditary angioedema who were previously enrolled in berotralstat studies - BCX7353-312

Biocryst Pharmaceuticals Inc.0 个研究点目标入组 110 人开始时间: 2024年5月16日最近更新: 2024年8月21日

研究概览

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•Males and non-pregnant, non-lactating females who are currently enrolled as a subject or were previously enrolled and did not discontinue due to an adverse event or due to noncompliance in BioCryst-sponsored Study 302 or 204., Able to provide written informed consent. Subjects who are aged 12 to 17 years of age must be able to read, understand, and be willing to sign an assent form in addition to an applicable representative providing informed consent, Would benefit from continued berotralstat treatment in the opinion of the investigator, Female subjects must meet at least 1 of the following requirements: a. Be a WOCBP (defined as a female following menarche and prior to becoming post-menopausal who has not had a hysterectomy or bilateral salpingectomy and bilateral oophorectomy) who agrees to use at least an acceptable effective contraceptive method during the study. b. Be a woman of nonchildbearing potential (defined as postmenopausal [no menses for at least 12 months without an alternative medical cause] or has had a hysterectomy or a bilateral salpingectomy and bilateral oophorectomy)., In the opinion of the investigator, the subject is expected to adequately comply with all required study procedures

•Any condition or situation, including medical history or changes in medical history, which, in the opinion of the investigator or sponsor, would interfere with the subject's safety or ability to participate in the study, Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent., Hypersensitivity to the active substance or to any of the excipients in the IMP, Use of other medications for long-term prophylaxis of HAE attacks at the Baseline visit or any time during the study. These include: C1-INH, tranexamic acid, androgens, or lanadelumab, Use of any other investigational medicinal product at the Baseline visit or any time during the study., Pregnancy or breastfeeding, Subjects with an immediate family relationship to either sponsor employees, the investigator, or employees of the study site who are named on the delegation log., Subjects who are held in an institution by a governmental or judicial order.

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