NCT01938378已完成4 期
An Open-label, Multicenter, Post-Marketing Requirement Study to Investigate the Safety and Tolerability of Octaplas™ in the Management of Pediatric Patients Who Require Therapeutic Plasma Exchange
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 41
- 试验地点
- 9
- 主要终点
- Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange.
研究概览
简要总结
To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs), thromboembolic events (TEEs) and by measuring safety laboratory parameters in pediatric patients who require therapeutic plasma exchange.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in whom therapeutic plasma exchange (TPE) is required.
- •Patient is male or female ≥ 2 years to ≤ 20 years of age.
- •Patient or patient's legal representative(s)/guardian(s) has /have given voluntarily written and signed informed consent before any study-related procedure is to be performed. If children are old enough (age usually deemed by each institution) to understand the risks and benefits of the study, they should also be informed and provide their written assent.
排除标准
- •Patient with known homozygous congenital deficiency of Protein S.
- •Exclusion Criteria:
- •Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product.
- •Patient has an already known IgA deficiency with documented antibodies against IgA.
- •Patient is currently participating in another interventional clinical study or has participated during the past 1 month prior to study inclusion. This is not applicable to non-interventional trials and does not exclude patients who have been exposed to Investigational Medicinal Product with a washout of at least 30 days from enrollment in LAS-
- •Concurrent participation in a device study will be considered on a case by case basis.
- •Patient is pregnant.
- •Use of Angiotensin-Converting-Enzyme-inhibitors within 72 hours of the start of the first infusion episode or planned used of these medications while on study.
结局指标
主要结局
Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange.
时间窗: up to 8 days including the 24 hour follow-up from treatment
Monitoring of adverse drug reactions caused by the octaplas™used for plasma exchange.
Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange.
时间窗: up to 8 days including the 24 hour follow-up from treatment
Monitoring of Thrombotic Events (TEs) and Thromboembolic Events (TEEs) caused by the octaplas™used for plasma exchange.
次要结局
- Assessment of Erythrocyte Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Carbon Dioxide Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Chloride Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Sodium Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Hematocrit Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Leukocyte Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Blood Urea Nitrogen Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Creatinine Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Potassium Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Mean Corpuscular Hemoglobin Concentration Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Glucose Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Hemoglobin Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Mean Corpuscular Volume Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Mean Corpuscular Hemoglobin Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Mean Ionized Calcium Levels(up to 8 days including the 24 hour follow-up)
- Investigator's Assessment of Overall Safety(up to 8 days including the 24 hour follow-up)
- Assessment of Mean Red Cell Distribution Width Levels(up to 8 days including the 24 hour follow-up)
研究者
研究点 (9)
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