A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).
研究概览
简要总结
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.
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
- 4 Years 至 71 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who:
- •Participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)
- •Were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were interested in participating in the Phase III clinical study with subcutaneous IgPro20 (study number ZLB04_009CR) (referred to as 'new' subjects)
- •Written informed consent
排除标准
- •Diagnosis of epilepsia
- •Insulin dependent diabetes
- •Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
- •History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension
研究组 & 干预措施
IgPro10
See Intervention Description
干预措施: Immunoglobulins Intravenous (Human) (Drug)
结局指标
主要结局
The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).
时间窗: During each infusion, and within 48 or 72 hours after the end of each infusion.
AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.
Influence of Infusion Rate on Temporally-Associated AEs
时间窗: Within 72 hours after each infusion
The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and \> 8 and ≤ 12 mg/kg/min). AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion.
Rate of AEs by Severity and Relationship
时间窗: For the duration of the study, up to approximately 29 months
The AE rate was the number of AEs over the number of infusions administered. Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
Number of Subjects With Clinically Significant Changes in Vital Signs.
时间窗: Before, during, and after each infusion.
Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
次要结局
- Annualized Rate of Acute Serious Bacterial Infections.(For the duration of the study, up to approximately 29 months)
- Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.(For the duration of the study, up to approximately 29 months.)
- Number of Days of Hospitalization.(For the duration of the study, up to approximately 29 months)
- Annualized Rate of Any Infection.(For the duration of the study, up to approximately 29 months.)
- Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.(Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.)