NCT00538915已完成3 期
Open Label, Phase III Safety, Efficacy, and Pharmacokinetic Study of NABI-IGIV 10% [Immune Globulin Intravenous (Human), 10%] in Subjects With Primary Immune Deficiency Disorders (PIDD)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 34
- 主要终点
- Rate of Serious Bacterial Infections (SBIs) Per Person-year on Treatment
研究概览
简要总结
The purpose of this study is to determine if NABI-IGIV (10%) [Immune Globulin Intravenous (Human), 10%] is safe and effective in preventing serious bacterial infections (SBIs) in the treatment of patients with primary immune deficiency disorders (PIDD) when compared to historical control data.
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
- 6 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥ 6 and ≤ 75, with a documented and confirmed pre-existing diagnosis of chronic primary immune deficiency (PIDD) with a low total immunoglobulin G (IgG) level and deficient antibody production before chronic therapy (i.e., X-linked agammaglobulinemia, common variable immunodeficiency (CVID), Hyper IgM Syndrome with immunoglobulin G (IgG) deficiency, etc).
- •Currently on immune globulin intravenous (IGIV) replacement therapy at a fixed interval and dosage with a total monthly dose of immune globulin intravenous (IGIV) between 300 and 800 mg/kg that has been stable for at least 3 months prior to screening.
- •Documented (within 3 months) plasma immunoglobulin G (IgG) trough level of >500 mg/dL on current immunoglobulin G (IgG) therapy [immunoglobulin G (IgG) levels may be obtained at screening if previous results not available].
- •Medical records documenting infections and treatment within the previous 2 years need to be available for review.
- •Subject or legal guardian(s) must have given written informed consent/assent.
- •If a menstruating female, have a negative serum or urine pregnancy test within 7 days prior to the first dose of Nabi-IGIV [immune globulin intravenous (Human) 10%] and agree to use an acceptable method of contraception or be at least one year post-menopausal or surgically sterile.
排除标准
- •Received any blood product [other than immune globulin intravenous (IGIV)] within the last 3 months prior to screening or received any investigational agent [other than immune globulin intravenous (IGIV)] within the last four weeks prior to receiving Nabi-IGIV [immune globulin intravenous (Human) 10%].
- •Known history of medically significant adverse reactions to other immunoglobulin G (IgG) or blood products.
- •Known selective immunoglobulin A (IgA) deficiency, history of allergic reaction to products containing immunoglobulin A (IgA) or has a history of antibodies to immunoglobulin A (IgA).
- •Known significant proteinuria and/or has a history of acute renal failure/or severe renal impairment [blood urea nitrogen (BUN) or creatinine more than 1.5 times the upper limit of normal].
- •Known history or current diagnosis of deep venous thrombosis.
- •Known medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), or chronic or recurrent neutropenia (absolute neutrophil count less than 500 mm3).
- •Current daily use of corticosteroids (> 10 mg of prednisone equivalent /day for > 30 days), immunosuppressants or immunomodulators. (Intermittent corticosteroid use during the study is allowable, if medically necessary.)
- •Known non-controllable arterial hypertension (systolic blood pressure (BP) > 160 mmHg and /or diastolic BP >100 mmHg.)
- •Known anemia at screening (hemoglobin <10 g/dL).
- •Subject is pregnant or lactating.
- •Known history of illicit drug use within 3 months prior to the administration of the investigational product and for the study duration.
- •Have any condition judged by the study physician to preclude participation in the study, including any psychological disorder, which might hinder compliance.
- •Known active viral or bacterial infection or symptoms/signs consistent with such an infection within the two weeks prior to the initial dose of investigational product infusion. Subjects may be on antibiotics as long as signs/symptoms of infection have been absent for two weeks prior to the initial infusion of investigational product (IP).
- •Expectation of non-compliance with the protocol procedures and visit schedule.
结局指标
主要结局
Rate of Serious Bacterial Infections (SBIs) Per Person-year on Treatment
时间窗: One year
Serious bacterial infections (SBIs) rate per person-years, including bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.
次要结局
未报告次要终点
研究者
研究点 (34)
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