CTRI/2025/11/097416招募中3 期
An open-label, single-arm, prospective, multicenter, phase 3 study to evaluate the efficacy, safety and pharmacokinetics of human normal immunoglobulin for intravenous use in adult and paediatric subjects with primary immunodeficiency syndrome
Bharat Serums and Vaccines Ltd4 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年11月25日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- measures the incidence of acute serious bacterial infections
研究概览
简要总结
This is a phase 3 open-label, single-arm, prospective, multicenter in adults and paediatric subjects with PID and on IVIG treatment (at least 3 infusion). Approximately, 42 subjects will be evaluated in the study. All subjects will receive IV infusions of the IVIG at the same dose and interval as was administered before enrolment into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with a confirmed clinical diagnosis of a PID
- •Has received 200-800 mg/kg of licensed IVIG therapy at 21 or 28 days intervals for 3 months
- •2 documented IgG trough levels of more than equal to 5 g per L are obtained at 2 infusion cycles
- •Subject is willing to comply with all requirements of the protocol
- •Females of child-bearing potential with a negative urine pregnancy test.
排除标准
- •Has secondary immunodeficiency
- •Newly diagnosed and has not been treated with immunoglobulin history of repeated reactions or hypersensitivity to IVIG
- •Has received blood products
- •Has an acute infection
- •Has profound anemia
- •Severe chronic condition such as renal failure, etc
- •Has a history of a malignant disease.
结局指标
主要结局
measures the incidence of acute serious bacterial infections
时间窗: End of study 12 months
次要结局
- Unable to perform normal daily activities(End of study 12 months)
- Unscheduled physician/clinic visits(End of study 12 months)
- Hospitalizations/admission in hospital due to infection(End of study 12 months)
- Use of Therapeutic antibiotics and duration of their use(End of study 12 months)
- Incidence of new infections other than acute serious bacterial infections(End of study 12 months)
研究者
Dr Ramesh Jagannathan
Bharat serums and Vaccines Ltd
研究点 (4)
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