EUCTR2016-003799-33-Outside-EU/EEA进行中（未招募）1 期
An open-label multicenter study to evaluate the safety and tolerability of higher infusion parameters of immune globulin subcutaneous (human), 20% liquid (Hizentra®) in subjects with primary immunodeficiency
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 51
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
- •1. Male or female on stable dose of IgPro20 (Hizentra) therapy. 2. Women of childbearing potential must be using and agree to continue using medically approved contraception (which must be discussed with the study doctor) and must have a negative pregnancy test at screening. 3. Subjects with PID, namely with a diagnosis of common variable immunodeficiency or X-linked agammaglobulinemia, as defined by the Pan American Group for Immune Deficiency and the European Society of Immune Deficiencies. 4. With infusion parameters as specified below:
- •Pump-Assisted Flow Rate Cohort subjects only
- •4a. Experience with pump-assisted infusions of IgPro20 at the tolerated flow rate of 25 mL/h per injection site for at least 1 month prior to study entry.
- •Pump-Assisted Volume Cohort subjects only
- •4b. Total weekly IgPro20 dose of = 50 mL (= 10 g).
- •4c. Experience with pump-assisted infusions of IgPro20 at tolerated volumes of 25 mL/injection site for at least 1 month prior to study entry.
- •Manual Push Flow Rate Cohort subjects only
- •4d. Experience with frequent (5-7 times per week) infusions of IgPro20 at the tolerated flow rate of approximately 0.5 mL/min (equivalent of 25-30 mL/h) per injection site for at least 1 month prior to study entry. The dose (volume) per injection site should not exceed 25 mL.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Ongoing serious bacterial infections at the time of screening. 2. Other significant medical conditions that could increase the risk to the subject. 3. Females who are pregnant, breast feeding, or planning a pregnancy during the course of the study. 4. Participation in a study with an Investigational Medicinal Product (IMP) other than IgPro20 within three months prior to enrollment.
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