申请企业

Pharming Americas BV

药品名称

RUCONEST, C1 Esterase Inhibitor (Recombinant)

状态

延迟

承诺描述

Conduct a study consisting of establishment and maintenance of a registry of HAE patients 13 years of age and older who are prescribed RUCONEST without plasma-derived C1 esterase inhibitors to evaluate the incidence of adverse events and time to symptom relief, as well as to characterize hypersensitivity reactions, thrombotic events, and the safety profile in pregnant and nursing women in the treatment of acute attacks of HAE in adult and adolescent patients. The study will continue until either a) three years have elapsed, or b) 100 patients have been enrolled, 35 of whom will be treated with RUCONEST for at least three attacks.

承诺状态描述

The study completion date has passed, and the study has not yet been completed.

报告接收日期

2020/9/14 0:00:00

批准日期

2014/7/16 0:00:00

截止日期

2019/1/16 0:00:00

CDER/CBER

CB

子类型标记