CTRI/2025/08/093411招募中3 期
An Open- Label, Multicenter, Phase III Clinical Study in India to Evaluate the Efficacy and Safety of Human Normal Immunoglobulin for Intravenous use (IVIG) in Chronic Immune Thrombocytopenia (ITP)
Bharat Serums and Vaccines Ltd8 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月1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
- 30
- 试验地点
- 8
- 主要终点
- The number and percentage of subjects with response (R).
研究概览
简要总结
This is an open-label, multicenter, Phase III clinical study to evaluate the efficacy and safety of IVIG in Indian adult Subjects with immune thrombocytopenia (ITP). Eligible adult subjects with chronic ITP will be enrolled in the study. Subjects will receive IVIG, and the efficacy and safety parameters will be assessed at specified intervals up to day 28. All the outcome measures will be assessed until the end of the study visit (day 28).
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
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of Chronic ITP of atleast 12 months duration Platelet count more than 30,000 per mm3 at screening.
- •absence of other conditions that could cause thrombocytopenia.
- •If subjects are currently being treated with corticosteroids the treatment regimen or dose must have been stable.
- •if subjects are currently being created with cyclophosphamide, azathioprine or attenuated androgens the treatment regimen and dose must have been stable.
- •Splenectomized subjects and both RhD positive and Rh-D negative subject can be included.
- •if subect is a female of child-bearing potential, she must have a negative result on urine-based human chorionic gonadotropin pregnancy test.
- •if subject is a female who is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study.
排除标准
- •Subect has history of any severe or anaphylactic reaction to IVIG or any other IgG preparation or its excipients.
- •Subject has received an IVIG preparation within 1 month prior to screening.
- •Received any blood, blood product, or blood derivative within the 1 month before screening.
- •Received Rituximab within the 3 months before screening.
- •Subject is pregnant or is in a period of lactation Subject has a severe renal impairment Subject is known to have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs with abuse potential in the past 12 months.
- •Subject has a history of deep vein thrombosis (DVT) or thrombotic complications of IVIG therapy subject has any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina Subject suffers from any acute or chronic medical conditions that may interfere with the conduct of study.
结局指标
主要结局
The number and percentage of subjects with response (R).
时间窗: up to day 28
次要结局
- The number and percentage of subjects with CR, LR, and NR(up to day 28)
- Time (in days) from treatment to R(up to day 28)
- Time (in days) from treatment to CR(up to day 28)
- Duration (in days) of R(up to day 28)
- Duration (in days) of CR(up to day 28)
研究者
Dr Ramesh Jagannathan
Bharat serums and Vaccines LTd
研究点 (8)
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