NCT00004695已完成不适用
Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency.
II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.
详细描述
PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to receive polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) or placebo.
Patients receive PEG-IL-2 or placebo by subcutaneous injection weekly for 18 months. Patients maintain a daily diary for 24 months.
Patients are followed every 4 months for 2 years.
Completion date provided represents the completion date of the grant per OOPD records
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Documented common variable immunodeficiency defined as a reduction of serum IgG by at least 2 standard deviations
- •In vitro lymphocyte proliferative response to PEG-IL-2 of at least 10 times more than unstimulated cultures
- •-Prior/Concurrent Therapy--
- •No biologic response modifier therapy (i.e., interferon, cyclosporin A) except prednisone (maximum 10 mg/day)
- •Concurrent treatment with same dosage intravenous gamma-globulin for at least 6 months is required
- •-Patient Characteristics--
- •Life expectancy: At least 24 months
- •Other: Not pregnant or nursing HIV negative
排除标准
- 未提供
研究者
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