NL-OMON54266招募中3 期
A Multicentre, Randomised, Double-blind, Parallel-group, Placebo controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES) - Evaluation of the Efficacy and Safety of Benralizumab in patients with HES
Astra Zeneca0 个研究点目标入组 3 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Adults with documented diagnosis of HES
- •* Stable HES treatment dose(s) and regimen for >= 4 weeks at the time of Visit 1
- •* Signs or symptoms of HES worsening/flare and/or laboratory abnormalities
- •indicative of HES worsening/flare (other than isolated eosinophilia) at Visit 1.
- •A documented history of 2 or more HES worsening/flares within 12 months prior
- •to Visit 1 requiring an escalation in therapy.
- •* At least one flare within the past 12 months must not be related to a
- •decrease in HES therapy during the 4 weeks prior to the flare.
- •For more details, see protocol section 5.1
排除标准
- •* Life-threatening HES and/or HES complication(s) as judged by the Investigator
- •* Current malignancy, or history of malignancy
- •* A history of known immunodeficiency disorder other than that explained by the
- •use of OCS or other therapy taken for HES. Positive human immunodeficiency
- •virus (HIV) test.
- •For more details, see protocol Section 5.2
研究者
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