NCT02810444已完成3 期
An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biotest
- 入组人数
- 81
- 试验地点
- 37
- 主要终点
- Rate of Acute Serious Bacterial Infections
研究概览
简要总结
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of Acute Serious Bacterial Infections
时间窗: approx. 12 month treatment period
The primary efficacy endpoint was the rate of acute serious bacterial infections, ie, the mean number of acute serious bacterial infections \[SBIs as defined by EMA and FDA\] per subject-year.
次要结局
- IgG Trough Levels (Total IgG) Before Each Infusion(approx. 12 month treatment period)
- Rate of Any Infections(approx. 12 month treatment period)
- Time to Resolution of Infections(approx. 12 month treatment period)
- Rate of Nonserious Infections(approx. 12 month treatment period)
- Rate of Time Lost From School/Work Due to Infections(approx. 12 month treatment period)
- Antibiotic Treatment Information(approx. 12 month treatment period)
- Hospitalization / Hospitalization Due to Infection(approx. 12 month treatment period)
- Fever Episodes(approx. 12 month treatment period)
研究者
研究点 (37)
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