An Observational, Multicenter Study to Evaluate Levels of Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Adult Patients With Hemophagocytic Lymphohistiocytosis (A-HLH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)
研究概览
简要总结
This observational study is designed to provide a better understanding of the potential use of interferon gamma (IFNγ) and IFNγ-inducible chemokines as markers of HLH disease activity in adults, and the potential of IFNγ to represent a therapeutic target.
详细描述
This is a observational study designed to determine the levels of pro-inflammatory markers in adult patients diagnosed with HLH and to assess the relationship between the biomarkers and disease activity in these patients during the HLH course. Inflammatory markers include IFNγ and IFNγ-induced chemokines C-X-C chemokine ligand 9 and C-X-C chemokine ligand 10.
In addition to the blood samples for the biomarker analysis, relevant information gathered by the treating physician will be collected in a data collection form. Whenever possible, collection of serum samples for biomarker analysis and relevant information should occur at HLH diagnosis, at regular time intervals during the treatment course (not more than once a week) up to resolution of HLH.
Blood samples will also be sent to the study sponsor (NovImmune S.A.) for cytokine testing. Before patient's samples are sent to the sponsor for testing, patient's name and any personal identifying information will be coded to protect participant's privacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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
- •Patients >=18 years old diagnosed with active HLH as established by the treating physician.
- •HLH forms of unknown origin or secondary to infections or rheumatologic disorders.
- •Should the diagnosis of primary HLH or malignancy become apparent after inclusion, the data collected will be analyzed separately as additional cohorts.
- •The patient must have consented to the use of their clinical data for research purposes at the site.
排除标准
- •Patients with primary HLH (diagnosed by the presence of homozygous mutations in a known HLH causative gene) and secondary HLH due to malignancy are excluded.
结局指标
主要结局
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)
时间窗: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10.
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9)
时间窗: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9.
Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg)
时间窗: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg.
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10)
时间窗: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10.
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B)
时间窗: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B.
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6)
时间窗: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6.
Mean Serum Concentration of Inflammatory Biomarker - Neopterin
时间窗: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin.
Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa)
时间窗: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa.
Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg)
时间窗: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg.
Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163)
时间窗: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163.
Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra)
时间窗: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra.
Mean Serum Concentration of White Blood Cells
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of white blood cells.
Mean Serum Concentration of Red Blood Cells
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of red blood cells.
Mean Serum Concentration of Hemoglobin
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin.
Mean Serum Concentration of Hematocrit
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit.
Mean Serum Concentration of Platelets
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets.
Mean Serum Concentration of Neutrophils
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils.
Mean Serum Concentration of Lymphocytes
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes.
Mean Serum Concentration of Monocytes
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes.
Mean Serum Concentration of Eosinophils
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils.
Mean Serum Concentration of Basophils
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils.
Mean Plasma Concentration of D-Dimer
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer.
Mean Plasma Concentration of Fibrinogen
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen.
Mean Activated Partial Thromboplastin Time (aPTT)
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the aPTT.
Mean Prothrombin Time
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the prothrombin time.
Mean Serum Concentration of C-Reactive Protein
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of c-reactive protein.
Mean Serum Concentration of Ferritin
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of ferritin.
Mean Plasma Concentration of Blood Urea Nitrogen
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of blood urea nitrogen.
Mean Serum Concentration of Creatinine
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine.
Mean Serum Concentration of Albumin
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin.
Mean Serum Concentration of Sodium
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium.
Mean Serum Concentration of Fasting Triglycerides
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fasting triglycerides.
Mean Serum Concentration of Total Bilirubin
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of total bilirubin.
Mean Serum Concentration of Conjugated Bilirubin
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of conjugated bilirubin.
Mean Serum Concentration of Alanine Aminotransferase
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alanine aminotransferase.
Mean Serum Concentration of Aspartate Aminotransferase
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of aspartate aminotransferase.
Mean Serum Concentration of Alkaline Phosphatase
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alkaline phosphatase.
Mean Serum Concentration of Lactate Dehydrogenase
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lactate dehydrogenase.
Mean Serum Concentration of Immunoglobulin G (IgG)
时间窗: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG.
次要结局
未报告次要终点