NCT00520494已完成4 期
A Multicenter Study on the Efficacy and Safety of Vivaglobin® in Previously Untreated Patients (PUPs) With Primary Immunodeficiency (PID)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12
研究概览
简要总结
The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.
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
- 1 Year 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent, age-adapted
- •Male or female aged 1 to 70 years
- •Diagnosis of primary humoral immunodeficiency
- •No prior immunoglobulin substitution therapy
- •IgG level of <5 g/L at screening
- •Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening
排除标准
- •Evidence of serious infection between screening and first treatment
- •Bleeding disorders that require medical treatments
- •Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity
- •Any condition likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
研究组 & 干预措施
Vivaglobin
Experimental
Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
干预措施: Vivaglobin (Drug)
结局指标
主要结局
Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12
时间窗: On Day 12
次要结局
- Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19(On Day 19)
- IgG Increase (Change From Baseline) on Day 12(Baseline to Day 12)
- Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12(On Day 12)
- Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26(On Day 26)
- Overall Rate of Infections(For the duration of the study, up to approximately 25 weeks)
- Total Serum IgG Trough Levels on Day 12(On Day 12)
- Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years)(At study completion, approximately Week 25)
- Total Serum IgG Trough Levels at Week 25(At Week 25)
- Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25(At Week 25)
- Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12(On Day 12)
- Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years)(At study completion, approximately Week 25)
- Number of Patients With Adverse Events (AEs) by Severity and Relatedness(For the duration of the study, up to approximately 25 weeks)
- Number of Patients With Local Reactions by Severity and Relatedness(For the duration of the study, up to approximately 25 weeks)
- Rate of Local Reactions by Severity and Relatedness(For the duration of the study, up to approximately 25 weeks)
- Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters(At Weeks 12 and 25)
- Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25(At Week 25)
- Use of Antibiotics for Infection Prophylaxis and Treatment(For the duration of the study, up to approximately 25 weeks)
- Rate of AEs by Severity and Relatedness(For the duration of the study, up to approximately 25 weeks)
- Number of Patients With Clinically Relevant Changes in Vital Signs(At the screening visit, before and after infusions (Days 1 to 5), and at the completion visit (Week 25))
研究者
研究点 (1)
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