NCT00751621已完成3 期
A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (IgPro20 EU Extension Study)
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
- 40
- 试验地点
- 14
- 主要终点
- Total Serum IgG Trough Levels
研究概览
简要总结
This study is a continuation of the study ZLB06_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with 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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with primary humoral immunodeficiency, namely with a diagnosis of Common variable immunodeficiency (CVID) as defined by the Pan-American Group for Immunodeficiency (PAGID) and the European Society for Immunodeficiencies (ESID), or X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or autosomal recessive agammaglobulinemia who have participated in the study ZLB06_001CR and who have tolerated IgPro well
- •Written informed consent
排除标准
- •Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined as total urine protein concentration > 0.2g/L)
- •Other significant medical conditions that could increase the risk to the subject
- •Females who are pregnant, breast feeding or planning a pregnancy during the course of the study
- •Participation in a study with an investigational medicinal product within three months prior to enrollment, except for ZLB06_001CR
- •Evidence of uncooperative attitude
- •Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study
- •Subjects who are employees at the investigational site, relatives or spouse of the investigator
结局指标
主要结局
Total Serum IgG Trough Levels
时间窗: Up to 42 months
The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.
次要结局
- Number of Infection Episodes(Up to 42 months)
- Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)(Up to 42 months)
- Annualized Rate of Infection Episodes(Up to 42 months)
- Health Related Quality of Life (Short Form 36 Health Survey)(At baseline and at the last available post-baseline observation for each subject (up to 42 months))
- Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections(Up to 42 months)
- Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections(Up to 42 months)
- Annualized Rate of Hospitalization Due to Infections(Up to 42 months)
- Number of Days of Hospitalization Due to Infections(Up to 42 months)
- Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit.(At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).)
- Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion(Up to 42 months)
- Use of Antibiotics for Infection Prophylaxis and Treatment(Up to 42 months)
- Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit.(At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).)
研究者
研究点 (14)
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