An Open-label, Multicenter Study to Assess the Pharmacokinetics, Safety, and Tolerability of Immune Globulin Subcutaneous (Human) IgPro20 in IG Treatment-naïve Subjects With Primary Immunodeficiency
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 8
- 试验地点
- 8
- 主要终点
- Trough concentration (Ctrough) Levels of IgPro20
研究概览
简要总结
This is an open-label, multicenter, phase 4 study in IG treatment-naïve participants with PID, conducted in the United States (US), to assess the PK, safety, and tolerability of IgPro20. The primary objective of this study is to characterize the PK of IgPro20 and to assess the safety and tolerability of IgPro20 in IG treatment-naïve participants with PID who are aged greater than or equal to (>=) 18 years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be aged >=18 years.
- •Participants must have a confirmed and documented diagnosis of PID, must be IG treatment-naïve and have an IgG level less than or equal to (<=) 400 milligrams per deciliter(mg/dL) at Screening.
排除标准
- •Participants with hyperprolinemia.
- •Participants who are receiving the following medications:
- •Systemic corticosteroids (prednisone or equivalent; average daily dose of greater than [>] 15 mg) from 4 weeks before Screening.
- •Any dose of systemic immunosuppressants within 9 months or 5 times the half-life (t½) plus 6 months before Screening, whichever is longer.
- •Any dose of biologic therapies with influence on the immune system (eg, tumor necrosis factor inhibitors, interleukin inhibitors, B-cell inhibitors), including investigational agents, within 12 months or 5 times the t½ plus 6 months before Screening, whichever is longer.
- •Participants who are currently receiving anti-coagulation therapy.
- •Participants with hypoalbuminemia, protein-losing enteropathies, and kidney diseases with proteinuria.
- •Participants with a documented history or a current diagnosis of a thromboembolic event(s) (eg, deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident, transient ischemic attack) or coagulopathy within 12 months before Screening.
- •Participants with severe dehydration and known blood disorders affecting viscosity.
- •Participants with aspartate aminotransferase and alanine aminotransferase concentration > 3 times the upper limit of normal (ULN; central laboratory) at Screening.
- •Participants with creatinine concentration > 1.5 times the ULN (central laboratory) at Screening.
- •Participants with new onset or worsening or severe cardiac, pulmonary, kidney disease, and liver disease.
- •Participants with malignancies of lymphoid cells such as chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma.
研究组 & 干预措施
IgPro20
All participants will receive a loading dose of IgPro20 daily from Day 1 to 5 in Week 1, followed by weekly administration of the maintenance dose of IgPro20 from Day 8 (Week 2) to Day 78 (Week 12).
干预措施: IgPro (Biological)
结局指标
主要结局
Trough concentration (Ctrough) Levels of IgPro20
时间窗: Up to Week 13
Number of Participants Experiencing Any Treatment-Emergent Adverse Event (TEAEs) or Serious TEAEs
时间窗: Up to Day 85
Number of TEAEs and Serious TEAEs Events
时间窗: Up to Day 85
TEAEs and Serious TEAEs Event Rates Per Days with Infusion
时间窗: Up to Day 85
次要结局
未报告次要终点