A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 23
- 试验地点
- 10
- 主要终点
- Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion
研究概览
简要总结
The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).
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
- •Subjects who have participated in study ZLB06_002CR and who have tolerated IgPro20 well.
- •Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years at the time of obtaining informed consent), as far as possible.
排除标准
- •Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of the first infusion.
- •Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine protein concentration >0.2 g/L or urine protein ++ by dipstick).
- •Pregnancy or nursing mother.
- •Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for ZLB06_002CR.
- •Subjects who are planning to donate blood during the study.
- •Re-entry of subjects previously participating in the current follow-up study.
- •Known or suspected antibodies to the IMP, or to excipients of the IMP.
结局指标
主要结局
Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion
时间窗: 24 weeks
The rate was calculated by counting all newly developed or worsened AEs within a subject and dividing by the total number of IgPro20 infusions administered to this subject. Subsequently, the median of these individual AE rates per infusion was calculated. AE rates were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related \[i.e., possibly related, probably related, or related\]).
次要结局
- Number of Days of Hospitalization Due to Infections.(24 weeks)
- Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections.(24 weeks)
- Overall Rate of AEs Per Infusion(24 weeks)
- Number of Subjects With Newly Developing or Worsening AEs(24 weeks)
- Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'(24 to 72 hours after infusion)
- IgG Trough Level(24 weeks)
- Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)(24 weeks)
- Number of Infection Episodes (Serious and Non-serious)(24 weeks)
- Duration of Use of Antibiotics for Infection Prophylaxis and Treatment(24 weeks)