A double-blind, randomized, placebo-controlled, cross-over study to evaluate the clinical efficacy and safety of subcutaneous administration of human plasma-derived C1-esterase inhibitor in the prophylactic treatment of hereditary angioedema

CSL Behring GmbH0 个研究点目标入组 80 人开始时间: 2013年10月22日最近更新: 2016年6月27日

试验速览

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•Run-In Period Inclusion Criteria:
•- Males or females aged 12 years or older.
•- A clinical diagnosis of hereditary angioedema type I or II.
•- Hereditary angioedema attacks over a consecutive 2-month period that required acute treatment, medical attention, or caused significant functional impairment.
•- For subjects who have used oral therapy for prophylaxis against HAE attacks within 3 months of Screening: use of a stable regimen within 3 months of Screening, with no plans to change
•Eligibility Criteria for Entering Treatment Period 1:
•Laboratory confirmation of type I or type II hereditary angioedema, including C1-esterase inhibitor functional activity less than 50% AND C4 antigen level below the laboratory reference range.
•No clinically significant abnormalities as assessed using laboratory parameters.
•During participation in the run-in period, subjects must have experienced hereditary angioedema attacks that required acute treatment, required medical attention, or caused significant functional impairment.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•-Run-In Period Exclusion Criteria:
•History of clinical significant arterial or venous thrombosis, or current history of a clinically significant prothrombotic risk.
•Incurable malignancies at screening.
•Any clinical condition that will interfere with the evaluation of C1-esterase inhibitor therapy.
•Clinically significant history of poor response to C1-esterase therapy for the management of hereditary angioedema.
•Receiving therapy prohibited by the protocol, including medications for hereditary angioedema prophylaxis.
•Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progesterone-containing products) within 3 months prior to the screening visit.

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