临床试验/NCT01397864

NCT01397864已完成不适用

C1 Inhibitor Treatment Registry to Assess the Safety and Immunological Profile of Ruconest in the Treatment of HAE Attacks

Pharming Technologies B.V.17 个研究点分布在 13 个国家目标入组 181 人开始时间: 2011年7月最近更新: 2025年4月8日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Pharming Technologies B.V.
入组人数: 181
试验地点: 17
主要终点: The primary objective is to observe the adverse event profile and insufficient efficacy, following single and repeated treatment with Ruconest or pdC1INH of acute angioedema attacks

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a non-interventional treatment Registry of Hereditary Angioedema (HAE) patients treated with C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (rhC1INH / Ruconest), to observe adverse events and insufficient efficacy, and to assess the immunological profile following single and repeated treatment with Ruconest.

详细描述

see below

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Decision to treat the HAE patient with C1 inhibitor (either Ruconest or pdC1INH)
•Patients must give written informed consent

排除标准

•A diagnosis of acquired C1INH deficiency (AAE)

研究组 & 干预措施

Hereditary Angioedema

干预措施: rhC1INH or pdC1INH (Drug)

结局指标

主要结局

The primary objective is to observe the adverse event profile and insufficient efficacy, following single and repeated treatment with Ruconest or pdC1INH of acute angioedema attacks

时间窗: December 2019

次要结局

To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies)(December 2019)

研究者

发起方

Pharming Technologies B.V.

申办方类型

Industry

责任方

Sponsor

研究点 (17)

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