Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Kinetics of IVIG-L in patients with hypogammaglobulinemia
研究概览
简要总结
The kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, were studied in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy.
详细描述
Sanquin has developed, in cooperation with the Finnish Red Cross Blood Transfusion Service (FRCBTS), a liquid intravenous immunoglobulin product, IVIG-L. The liquid formulation of intravenous immunoglobulin simplifies the infusion, eliminates possible mistakes in the reconstitution with water for injections and reduces the space requirements in storage.
In addition to the donor selection and donor screening, several viral safety steps have been included into the production process.
In this clinical trial, the efficacy and safety of IVIG-L in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy, will be studied. IVIG-L will also be studied in patients with chronic ITP (KB98001). Data from both studies will be used for an application for marketing authorisation in Finland and the Netherlands.
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
- •Primary a- or hypogammaglobulinemia, particularly patients with X-linked agammaglobulinemia (XLA) or Common Variable Immunodeficiency (CVID)
- •Used to replacement treatment with intravenous immunoglobulin with 2-4 week intervals
- •A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose)
- •Age > 18 years
- •The patient/legally acceptable representative has signed the consent form
排除标准
- •Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
- •Known allergic reactions to human plasma or plasma products
- •Have an ongoing progressive terminal disease, including HIV infection
- •Pregnancy or lactation
- •Known insufficiency of coronary or cerebral circulation
- •Have renal insufficiency (plasma creatinine > 115µmol/L)
- •Have an ongoing active disease causing general symptoms, e.g. chronic active hepatitis, persistent enterovirus infection.
- •Have IgA deficiency, and anti-IgA antibodies have been detected
- •Active systemic lupus erythematosus (SLE)
结局指标
主要结局
Kinetics of IVIG-L in patients with hypogammaglobulinemia
Efficacy of IVIG-L in patients with hypogammaglobulinemia
Safety of IVIG-L in patients with hypogammaglobulinemia
次要结局
- To compare the IgG trough level
- To compare dosage and treatment intervals