NCT00417573已完成2 期
Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
The Center for Rheumatic Disease, Allergy, & Immunology2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2004年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Lab values ck'ed baseline and with each treatment, and 15 mo. visit
研究概览
简要总结
- This is the first study, that we are aware of, that will evaluate the efficacy of IgIV in patients with IgG subclass deficiency.
- Will provide data for further collaboration in extending study to involve other immunological centers in the United States to study patients with similar disease.
详细描述
*10 consenting adults (18 or older) will receive IgIV (Gamunex 10%) monthly at a dose of 400mg/kg body weight IV at 3ml/minute. Comprehensive labs will be monitored at each visit, as well as clinical eval, plus patients will complete a questionnaire each time. There is also a 3 month follow-up visit after completion of therapy. Specific xrays will be done at the beginning and with the last treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18 or older) with deficiency in one or more IgG subclasses with documented history of recurrent infections limited to upper or lower respiratory tract, urinary, and/or skin.
排除标准
- •Patients with panhypogammaglobulinemia or selective IgA deficiency.
结局指标
主要结局
Lab values ck'ed baseline and with each treatment, and 15 mo. visit
Xray of Chest and sinus baseline and on 12th and last treatment
Clinical assessment baseline, every treatment, and 15 mo.
次要结局
- Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist.
研究者
研究点 (2)
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