DRKS00008783已完成2 期
Safety of Abatacept in patients with interstitial lung disease and Common variable immunodeficiency (CVID) and related disease - SAI
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Diagnosis of CVID according to ESID/PAGID criteria or diagnosis of related disorders which fulfill the diagnostic criteria for CVID
- •2. Interstitial lung disease or granuloma diagnosed by chest CT positive for nodules, lines or ground-glass signs
- •3. Age 18 years and above
- •4. Signed written informed consent
- •5. Not responsive to steroid monotherapy for a minimum of three months or intolerance of steroid therapy
- •6. Need for intervention measured by either reduced oxygen saturation, drop of oxygen saturation under exercise or reduced DLCOcSB
- •progress of interstitial lung disease measured by progressive changes in the CT scan of the lung
排除标准
- •1. Patient without legal capacity who is unable to understand the nature, significance and consequences of the study
- •2. Other immunosuppressive therapy including biologicals beyond steroid at screening phase
- •3. Previous treatment with Abatacept
- •4. Active Hepatitis B infection or tuberculosis infection
- •5. Other Uncontrolled infection
- •6. Lymphoma within the past 5 years
- •7. Pregnancy indicated by positive urine pregnancy test at screening
- •8. Breast feeding patients
- •9. Fertile patients refusing to use safe contraceptive methods during the study
- •10. Simultaneous participation in other interventional clinical trials
研究者
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