NL-OMON45905撤回不适用
A prospective outcome study on patients with profound combined immunodeficiency - pCID
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •Clinical and immunological criteria determine inclusion irrespective of the
- •genetic diagnosis.
- •T cell criteria (2 out of 4)
- •o Reduced T cell counts (CD4 : <700, if <2y ; <500, if 2-4y ; <300,
- •if >4y ; CD8 : <350, if <2y ; <250, if 2-4y ; <150, if >4y)
- •o Reduced thymic function (CD45RA+CD62L+ or CD45RA+CD31+
- •of CD4+ <30% <2y, <25% 2-6y, <20% >6y)
- •o Impaired T cell proliferation (PHA response <30% of lower limit of
- •o Elevated fraction of */* T cells (>15% of total CD3+ T cells)
- •AND Clinical criteria
- •* At least one major infection criteria (viral, bacterial, opportunistic)
- •* At least one major immune dysregulation criteria (granulomas,
- •lymphoproliferative disease, unexplained interstitial lung disease,
- •inflammatory bowel disease, autoantibody mediated disease,
- •vasculitis) OR
- •* At least one malignancy criteria (lymphoid malignancies and
- •virally induced malignancies)
- •AND Age ><= 1yr and <<= 16yr at study inclusion
排除标准
- •No written consent available No written informed consent of
- •patient or parents in case of minors available or no assent of
- •minor if applicable;* Patients with a clinical diagnosis of SCID or Omenn syndrome
- •within the first year of life
- •* P-CID Patients for whom decision for HSCT is taken at age <1yr
- •* Patients with Wiskott-Aldrich syndrome and CD40 Ligand
- •Deficiency, because disease-specific prognosis and treatment
- •data are available
- •* Patients undergoing gene therapy or ADA enzyme replacement
- •will be followed using the same parameters, but will not be
- •included in the analysis
研究者
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