A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects 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
- 21
- 试验地点
- 4
- 主要终点
- Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)
研究概览
简要总结
The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.
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
- •Subjects with primary humoral immunodeficiency who have participated in the study ZLB04_009CR (NCT00419341), namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or X-linked Agammaglobulinemia (XLA) as defined by PAGID and ESID
- •Women of childbearing potential must be using and agree to continue using medically approved contraception and must have a negative pregnancy test at screening
- •Written informed consent
排除标准
- •Ongoing serious bacterial infection at the time of screening
- •Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma, and immunodeficiency with thymoma
- •Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
- •Other significant medical conditions that could increase the risk to the patient
- •Females who are pregnant, breast-feeding or planning a pregnancy during the course of the study
- •A positive result at screening on any of the following viral markers: Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV)
- •Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration > 2.5 times Upper Normal Limit (UNL) at Completion Visit of study ZLB04_009CR (NCT00419341)
- •Creatinine concentration > 1.5 times UNL at Completion Visit of study ZLB04_009CR (NCT00419341)
- •Participation in a study with an investigational product other than IgPro20 within 3 months prior to enrollment
- •Evidence of uncooperative attitude
- •Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
- •Subjects who are employees at the investigational site, relatives or spouse of the investigator
研究组 & 干预措施
IgPro20
The IgPro20 dose will be the same as in the previous pivotal study ZLB04_009CR (NCT00419341) infused subcutaneously weekly or twice a week (in the latter case, half of a weekly dose will be used)
干预措施: IgPro20 (Biological)
结局指标
主要结局
Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)
时间窗: For the duration of the study, up to approximately 104 weeks
The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.
Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population)
时间窗: For the duration of the study, up to approximately 104 weeks
The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.
次要结局
- Annualized Rate of Any Infection(For the duration of the study, up to approximately 104 weeks)
- Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion(Within 24 or 72 hours after each infusion)
- Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations(Before infusion at Weeks 1, 24, 48, 72, and 96)
- Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection(For the duration of the study, up to approximately 104 weeks)
- Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection(For the duration of the study, up to approximately 104 weeks)
- Number of Days of Hospitalization Due to Infection(For the duration of the study, up to approximately 104 weeks)
- Annualized Rate of Hospitalization Due to Infection(For the duration of the study, up to approximately 104 weeks)
- Use of Antibiotics for Infection Prophylaxis and Treatment(For the duration of the study, up to approximately 104 weeks)
- Rate of All AEs by Relatedness and Severity(For the duration of the study, up to approximately 104 weeks)
- Relatedness and Severity of All AEs (Percentage of Total AEs)(For the duration of the study, up to approximately 104 weeks)
- Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion(Within 24 or 72 hours after each infusion)
- Number of Subjects Reporting Mild, Moderate, or Severe Local AEs(For the duration of the study, up to approximately 104 weeks)
- Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs(At weeks 1, 12, 24, 36, 48, 60, 72, 84, and 96)
- Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters(At Week 1, and study completion (approximately 104 weeks))
- Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers(At Week 1, and study completion (approximately 104 weeks))