A Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics 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
- 51
- 试验地点
- 20
- 主要终点
- Total Serum IgG Trough Levels
研究概览
简要总结
The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
详细描述
This study consisted of a 12-week wash-in/wash-out period followed by a 28-week efficacy period. During the 28-week efficacy period, subjects visited the study site at least every 4 weeks for efficacy and safety evaluations and additionally recorded details regarding IgPro20 dose and certain aspects of efficacy and safety in a diary. Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects during 1 treatment interval at steady-state (Week 28 ± 1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 European Society for Immunodeficiencies (ESID), X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or Autosomal Recessive Agammaglobulinemia
- •Chest X-ray or CT scan obtained within 1 year prior to enrolment
排除标准
- •Newly diagnosed PID, i.e. subjects who have not previously received immunoglobulin replacement therapy
- •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
- •Allergic or other severe reactions to immunoglobulins or other blood products associated with high anti-IgA
- •Additional criteria may apply and examination by an investigator is required to determine eligibility.
研究组 & 干预措施
IgPro20
干预措施: Human Normal Immunoglobulin for Subcutaneous Administration (IGSC) (Biological)
结局指标
主要结局
Total Serum IgG Trough Levels
时间窗: Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (IgPro20 treatment)
Total IgG trough levels for IgPro20 treatment at steady state were compared with documented trough level data for IgG treatment received prior to enrolling in the study (either subcutaneous or intravenous IgG). For this purpose, 6 consecutive IgPro20 trough values (obtained prior to infusions 12 to 17) per subject were aggregated to the subject's median value and then median values across subjects were summarised using descriptive statistics. The same procedure was applied to pre-study treatment using the 3 most recent IgG trough values ≥ 5 g/L obtained prior to the first IgPro20 infusion.
次要结局
- Annual Rate of the Number of Days of Hospitalization Due to Infections(Efficacy period: week 12 to week 40 after study start or to the completion visit)
- Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population)(Efficacy period: week 12 to week 40 after study start or to the completion visit)
- Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population)(Efficacy period: week 12 to week 40 after study start or to the completion visit)
- Annual Rate of Infection Episodes(Efficacy period: week 12 to week 40 after study start or to the completion visit)
- Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections(Efficacy period: week 12 to week 40 after study start or to the completion visit)
- Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment(Efficacy period: week 12 to week 40 after study start or to the completion visit)