NCT01199705已完成3 期
A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 25
- 试验地点
- 11
- 主要终点
- IgG Trough Level
研究概览
简要总结
The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy
- •Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent
- •Written informed consent
排除标准
- •Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy
- •Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening
- •Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma
- •Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening
- •Pregnancy or nursing mother
- •A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus
- •Participation in a study with other investigational product during this study and within 3 months prior to screening
- •Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during the study
结局指标
主要结局
IgG Trough Level
时间窗: During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24
Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.
次要结局
- Number of Infection Episodes (Serious and Non-serious) by Study Period(Up to 36 weeks)
- Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population(Up to 36 weeks)
- Number of Days of Hospitalization Due to Infections by Study Period(Up to 36 weeks)
- Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population(Up to 36 weeks)
- Duration of Use of Antibiotics for Infection Prophylaxis and Treatment(Up to 36 weeks)
- Rate of All Adverse Events by Relatedness and Seriousness(For the duration of the study, up to 36 weeks)
- Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period(Up to 36 weeks)
- Rate of Mild, Moderate, or Severe Local Reactions(For the duration of the study, up to 36 weeks)
研究者
研究点 (11)
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