IRCT20101012004920N9尚未招募3 期
Evaluation of Efficacy and Possible Side Effects of Human Polyclonal Antibodies (IVIg) of Medvac Biopharma Co. in the Treatment of Patients with Primary Immunodeficiency disorder (PID)
Medvac BioPharma Company0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 years 至 40 years（—）
- 性别
- All
入选标准
- •Patients with congenital or primary immunodeficiency of 2-40years old who weigh 10 kg or more.
- •Previously confirmed Congenital or Primary Immunodeficiency which have received at least six months of IVIg treatment
- •Willingness to cooperate and obtain informed written consent from the patient, parent or legal guardian of the child
排除标准
- •Patients with secondary immunodeficiency, newly diagnosed primary immunodeficiency and without treatment, dysglobunemia
- •History of hypersensitivity to IVIg or other injectable forms of Ig or history of thrombotic complications of IVIg treatment
- •Patients with IgA deficiency
- •Concomitant use of corticosteroids, chemotherapy, immunosuppressive drugs
- •Patients with HIV, hepatitis A, B, C or a history of these diseases
- •History of severe seizures or migraines
- •Chronic kidney diseases, liver and various malignancies
- •Nephrotic syndrome
- •DVT history
- •Acute bacterial infection in the last 7 days
研究者
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