EUCTR2014-003607-30-Outside-EU/EEA进行中（未招募）不适用
A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female aged 2 to 75 years
- •- Subjects with primary humoral immunodeficiency, namely with a diagnosis of: CVID (Common Variable Immunodeficiency) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or XLA (X-linked Agammaglobulinemia)
- •- Written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 17
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •- Newly diagnosed PID
- •- Evidence of an active serious infection at the time of screening (i.e., but not limited to: bacteremia/septicemia, pneumonia, fungal osteomyelitis)
- •- Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma
- •- Known hyperprolinemia
- •- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria
- •- Allergic reactions to immunoglobulins or other blood products
- •- Known antibodies to Immunoglobulin A (IgA)
- •- The subject is receiving steroids (oral and parenteral, daily = 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants
- •- Female who is pregnant, breast feeding or planning a pregnancy during the course of the study
- •- Participation in a study with an investigational product other than (IVIG) within 1 month prior to enrollment
- •- A positive result at screening on any of the following viral markers: Human Immunodeficiency Virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV)
- •- Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration > 2.5 times the upper normal limit (UNL)
- •- Creatinine concentration > 1.5 times the UNL
- •- Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
研究者
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