Prospective Open-Label Study of Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Patients With Hypo- or Agammaglobulinemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 12
- 主要终点
- Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution)
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be eligible for study entry if they:
- •are at least 18 years old
- •have a form of primary immunodeficiency (PID) as described by Rosen et al, 1999 16 manifesting as agammaglobulinemia (X-linked) or hypogamma-globulinemia (common variable immunodeficiency), requiring immunoglobulin replacement therapy
- •have had regular treatment for at least three months with either intravenous immunoglobulin preparations or immunoglobulin preparations for intramuscular use given subcutaneously
- •have serum IgG levels greater than or equal to 5 g/L as determined by the local laboratory at screening
- •if female of childbearing potential, agree to employ adequate birth control measures during the study
- •have given written informed consent
排除标准
- •Subjects will not be eligible for study entry if they:
- •had severe adverse reactions to treatment with immunoglobulin preparations during the last three treatments before inclusion into the study
- •suffer from documented selective IgA deficiency with antibodies against IgA
- •have an acute infection that requires intravenous antibiotic treatment (Last treatment day should be seven days before study entry.)
- •are known to be infected with HIV, HCV, or HBV
- •are at high risk of contracting blood-borne viral infections through parenteral drug abuse or life style
- •suffer from congestive heart failure and receive on-demand treatment with furosemide
- •show renal dysfunction defined as serum creatinine greater than or equal to 1.5 mg/dL at baseline visit
- •received another investigational drug in the three weeks preceding study entry
- •in case of females, are pregnant or nursing mothers
结局指标
主要结局
Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution)
时间窗: 21 days after each infusion (i.e., before the next infusion) of the study drug and at the last visit
次要结局
未报告次要终点