NCT00157079已完成3 期
A Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders
Baxalta now part of Shire22 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2002年6月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 22
- 主要终点
- Mean number of acute serious bacterial infections per participant per year
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
入排标准
- 年龄范围
- 24 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration
- •Diagnosis of a PID disorder as defined by World Health Organization criteria for which the subject has been receiving a regimen of IGIV infusions every 21 to 28 days over a period of at least 4 months pre-study at a dose of 300-600 mg/kg body weight
- •Subjects > 24 months of age
- •A negative serum pregnancy test for any female subject who is of childbearing potential.
排除标准
- •Subjects sero-positive at enrollment for one or more of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (HCV), antibodies to human immunodeficiency virus (HIV) Types 1 or 2
- •Subjects with levels of alanine amino transferase (ALT) and aspartate amino transferase (AST) > 2.5 times the upper limit of normal for the testing laboratory. An AST > 2.5 times the upper limit of normal is allowable, if the ALT does not exceed the upper limit of the reference range for the testing laboratory
- •Subjects with neutropenia (defined as an ANC >= 1,000/mm3)
- •Subjects with serum creatinine levels greater than two times the upper limit of normal for age and gender
- •Subjects with malignancy or a history of malignancy
- •Subjects who received any blood or blood product exposure other than an IGIV and/or immune serum globulin (ISG) preparation within the 6 months prior to study entry
- •Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV and/or ISG infusions
- •Subjects with selective complete IgA deficiency
- •Subjects with moderate levels of anti-IgA antibodies (>150), or subjects with lower anti-IgA antibodies who are naive to IGIV treatment. (Subjects with lower levels of IgA antibodies, whom the investigators know to have tolerated IgA containing IGIV preparations in the past, may be included if the investigator is comfortable with this)
- •Subjects receiving antibiotic therapy for the treatment of infection within 30 days prior to enrollment
- •Subjects who receive prophylactic antibiotics as part of their care regimen
- •Subjects participating in another clinical study involving an investigational product or device within 30 days prior to study entry
结局指标
主要结局
Mean number of acute serious bacterial infections per participant per year
时间窗: Throughout the study period of 18 months
次要结局
未报告次要终点
研究者
研究点 (22)
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