Hemophagocytic Lymphohistiocytoses
Conditions
Keywords
Hemophagocytic Lymphohistiocytosis, Interferon Gamma, IFNγ, Biomarkers, Inflammatory Markers
Brief summary
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.
Detailed description
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.
Interventions
OTHERBlood Draws Data Collection
Sponsors
Brigham and Women's Hospital
Harvard Medical School (HMS and HSDM)
Swedish Orphan Biovitrum
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) | 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) | 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) | 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) | 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) | 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) | 11 months | Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6. |
| Mean Serum Concentration of Hemoglobin | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin. |
| Mean Serum Concentration of Hematocrit | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit. |
| Mean Serum Concentration of Inflammatory Biomarker - Neopterin | 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) | 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) | 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) | 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) | 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 | 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 | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of red blood cells. |
| Mean Serum Concentration of Platelets | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets. |
| Mean Serum Concentration of Neutrophils | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils. |
| Mean Serum Concentration of Lymphocytes | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes. |
| Mean Serum Concentration of Monocytes | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes. |
| Mean Serum Concentration of Eosinophils | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils. |
| Mean Serum Concentration of Basophils | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils. |
| Mean Plasma Concentration of D-Dimer | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer. |
| Mean Plasma Concentration of Fibrinogen | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen. |
| Mean Activated Partial Thromboplastin Time (aPTT) | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the aPTT. |
| Mean Prothrombin Time | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the prothrombin time. |
| Mean Serum Concentration of C-Reactive Protein | 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 | 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 | 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 | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine. |
| Mean Serum Concentration of Albumin | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin. |
| Mean Serum Concentration of Sodium | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium. |
| Mean Serum Concentration of Fasting Triglycerides | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 11 months | Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG. |
Countries
United States
Participant flow
Recruitment details
This Phase 4 observational study was conducted in adult patients diagnosed with hemophagocytic lymphohistiocytosis (A-HLH) at a single center in the United States of America.
Pre-assignment details
A total of 14 patients were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| A-HLH Patients Patients diagnosed with A-HLH. | 10 |
| M-HLH Patients Patients diagnosed with HLH in the context of a malignancy. | 4 |
| Total | 14 |
Baseline characteristics
| Characteristic | A-HLH Patients | M-HLH Patients | Total |
|---|---|---|---|
| Age, Continuous | 44.8 years STANDARD_DEVIATION 12.4 | 54.3 years STANDARD_DEVIATION 4.9 | 47.5 years STANDARD_DEVIATION 11.5 |
| Race/Ethnicity, Customized African descent | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 8 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized Mixed/multi-racial | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Mean Activated Partial Thromboplastin Time (aPTT)
Blood samples was collected at various times after HLH diagnosis to determine the aPTT.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Activated Partial Thromboplastin Time (aPTT) | 27.98 seconds | Standard Deviation 8.21 |
Primary
Mean Plasma Concentration of Blood Urea Nitrogen
Blood samples was collected at various times after HLH diagnosis to determine the concentration of blood urea nitrogen.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Plasma Concentration of Blood Urea Nitrogen | 17.3 mg/dL | Standard Deviation 8.3 |
| M-HLH Patients | Mean Plasma Concentration of Blood Urea Nitrogen | 50.2 mg/dL | Standard Deviation 37.3 |
Primary
Mean Plasma Concentration of D-Dimer
Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| A-HLH Patients | Mean Plasma Concentration of D-Dimer | 2300.0 microgram (mcg)/mL |
Primary
Mean Plasma Concentration of Fibrinogen
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Plasma Concentration of Fibrinogen | 306.8 milligram (mg)/dL | Standard Deviation 145.7 |
| M-HLH Patients | Mean Plasma Concentration of Fibrinogen | 172.5 milligram (mg)/dL | Standard Deviation 83 |
Primary
Mean Prothrombin Time
Blood samples was collected at various times after HLH diagnosis to determine the prothrombin time.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Prothrombin Time | 13.81 seconds | Standard Deviation 0.9 |
| M-HLH Patients | Mean Prothrombin Time | 16.75 seconds | Standard Deviation 4.6 |
Primary
Mean Serum Concentration of Alanine Aminotransferase
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alanine aminotransferase.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Alanine Aminotransferase | 93.2 international units (IU)/L | Standard Deviation 145.6 |
| M-HLH Patients | Mean Serum Concentration of Alanine Aminotransferase | 54.8 international units (IU)/L | Standard Deviation 35.1 |
Primary
Mean Serum Concentration of Albumin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Albumin | 3.68 gram/dL | Standard Deviation 0.55 |
| M-HLH Patients | Mean Serum Concentration of Albumin | 3.21 gram/dL | Standard Deviation 0.87 |
Primary
Mean Serum Concentration of Alkaline Phosphatase
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alkaline phosphatase.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Alkaline Phosphatase | 121.1 IU/L | Standard Deviation 98.8 |
| M-HLH Patients | Mean Serum Concentration of Alkaline Phosphatase | 258.2 IU/L | Standard Deviation 188.5 |
Primary
Mean Serum Concentration of Aspartate Aminotransferase
Blood samples was collected at various times after HLH diagnosis to determine the concentration of aspartate aminotransferase.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Aspartate Aminotransferase | 66.0 IU/L | Standard Deviation 105.8 |
| M-HLH Patients | Mean Serum Concentration of Aspartate Aminotransferase | 48.6 IU/L | Standard Deviation 35.4 |
Primary
Mean Serum Concentration of Basophils
Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Basophils | 0.181 cells*10^3/mcL | Standard Deviation 0.516 |
| M-HLH Patients | Mean Serum Concentration of Basophils | 0.222 cells*10^3/mcL | Standard Deviation 0.399 |
Primary
Mean Serum Concentration of Conjugated Bilirubin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of conjugated bilirubin.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Conjugated Bilirubin | 0.25 mg/dL | Standard Deviation 0.31 |
| M-HLH Patients | Mean Serum Concentration of Conjugated Bilirubin | 12.80 mg/dL | Standard Deviation 1.13 |
Primary
Mean Serum Concentration of C-Reactive Protein
Blood samples was collected at various times after HLH diagnosis to determine the concentration of c-reactive protein.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of C-Reactive Protein | 27.97 mg/dL | Standard Deviation 31.13 |
| M-HLH Patients | Mean Serum Concentration of C-Reactive Protein | 13.35 mg/dL | Standard Deviation 12.06 |
Primary
Mean Serum Concentration of Creatinine
Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Creatinine | 0.768 mg/dL | Standard Deviation 0.293 |
| M-HLH Patients | Mean Serum Concentration of Creatinine | 1.449 mg/dL | Standard Deviation 0.748 |
Primary
Mean Serum Concentration of Eosinophils
Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Eosinophils | 0.252 cells*10^3/mcL | Standard Deviation 0.707 |
| M-HLH Patients | Mean Serum Concentration of Eosinophils | 1.002 cells*10^3/mcL | Standard Deviation 2.449 |
Primary
Mean Serum Concentration of Fasting Triglycerides
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fasting triglycerides.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M-HLH Patients | Mean Serum Concentration of Fasting Triglycerides | 645.0 mg/dL |
Primary
Mean Serum Concentration of Ferritin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of ferritin.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Ferritin | 5050.2273 ng/mL | Standard Deviation 5302.9183 |
| M-HLH Patients | Mean Serum Concentration of Ferritin | 24331.4517 ng/mL | Standard Deviation 38189.6158 |
Primary
Mean Serum Concentration of Hematocrit
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Hematocrit | 30.03 percentage of volume of red cells | Standard Deviation 5.75 |
| M-HLH Patients | Mean Serum Concentration of Hematocrit | 28.55 percentage of volume of red cells | Standard Deviation 3.55 |
Primary
Mean Serum Concentration of Hemoglobin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Hemoglobin | 10.11 gram/deciliter (g/dL) | Standard Deviation 1.93 |
| M-HLH Patients | Mean Serum Concentration of Hemoglobin | 9.83 gram/deciliter (g/dL) | Standard Deviation 1.09 |
Primary
Mean Serum Concentration of Immunoglobulin G (IgG)
Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Immunoglobulin G (IgG) | 763.6 mg/dL | Standard Deviation 579.3 |
| M-HLH Patients | Mean Serum Concentration of Immunoglobulin G (IgG) | 996.0 mg/dL | — |
Primary
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) | 2079.286 picogram/milliliter (pg/mL) | Standard Deviation 2659.228 |
| M-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) | 15197.143 picogram/milliliter (pg/mL) | Standard Deviation 21288.948 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9) | 4474.685 pg/mL | Standard Deviation 10207.638 |
| M-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9) | 6602.853 pg/mL | Standard Deviation 7777.846 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg) | 81.782 pg/mL | Standard Deviation 140.87 |
| M-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg) | 809.810 pg/mL | Standard Deviation 769.433 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10) | 24.157 pg/mL | Standard Deviation 87.64 |
| M-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10) | 266.948 pg/mL | Standard Deviation 257.77 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B) | 2.140 pg/mL | Standard Deviation 0 |
| M-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B) | 2.140 pg/mL | Standard Deviation 0 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6) | 3.455 pg/mL | Standard Deviation 3.727 |
| M-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6) | 29.695 pg/mL | Standard Deviation 52.403 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Neopterin
Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Neopterin | 33.995 nanomoles | Standard Deviation 29.227 |
| M-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Neopterin | 839.775 nanomoles | Standard Deviation 950.07 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163) | 1431.488 nanogram (ng)/mL | Standard Deviation 1078.058 |
| M-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163) | 878.880 nanogram (ng)/mL | — |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra) | 2273.193 pg/mL | Standard Deviation 2383.154 |
| M-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra) | 27052.498 pg/mL | Standard Deviation 24009.516 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg) | 34.178 pg/mL | Standard Deviation 25.95 |
| M-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg) | 1069.215 pg/mL | Standard Deviation 1987.409 |
Primary
Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa) | 6.050 pg/mL | Standard Deviation 6.405 |
| M-HLH Patients | Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa) | 14.308 pg/mL | Standard Deviation 12.01 |
Primary
Mean Serum Concentration of Lactate Dehydrogenase
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lactate dehydrogenase.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Lactate Dehydrogenase | 539.8 IU/L | Standard Deviation 660.8 |
| M-HLH Patients | Mean Serum Concentration of Lactate Dehydrogenase | 362.7 IU/L | Standard Deviation 274.4 |
Primary
Mean Serum Concentration of Lymphocytes
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Lymphocytes | 3.636 cells*10^3/mcL | Standard Deviation 10.88 |
| M-HLH Patients | Mean Serum Concentration of Lymphocytes | 1.956 cells*10^3/mcL | Standard Deviation 3.424 |
Primary
Mean Serum Concentration of Monocytes
Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Monocytes | 1.306 cells*10^3/mcL | Standard Deviation 3.602 |
| M-HLH Patients | Mean Serum Concentration of Monocytes | 0.948 cells*10^3/mcL | Standard Deviation 1.721 |
Primary
Mean Serum Concentration of Neutrophils
Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Neutrophils | 7.715 cells*10^3/mcL | Standard Deviation 14.003 |
| M-HLH Patients | Mean Serum Concentration of Neutrophils | 22.303 cells*10^3/mcL | Standard Deviation 37.944 |
Primary
Mean Serum Concentration of Platelets
Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Platelets | 182.6 cells*10^3/mcL | Standard Deviation 138.2 |
| M-HLH Patients | Mean Serum Concentration of Platelets | 92.9 cells*10^3/mcL | Standard Deviation 87.1 |
Primary
Mean Serum Concentration of Red Blood Cells
Blood samples was collected at various times after HLH diagnosis to determine the concentration of red blood cells.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Red Blood Cells | 3.420 cells*10^6/mcL | Standard Deviation 0.745 |
| M-HLH Patients | Mean Serum Concentration of Red Blood Cells | 3.206 cells*10^6/mcL | Standard Deviation 0.396 |
Primary
Mean Serum Concentration of Sodium
Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Sodium | 136.4 millimoles/L | Standard Deviation 3.7 |
| M-HLH Patients | Mean Serum Concentration of Sodium | 135.3 millimoles/L | Standard Deviation 3.2 |
Primary
Mean Serum Concentration of Total Bilirubin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of total bilirubin.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of Total Bilirubin | 0.590 mg/dL | Standard Deviation 0.559 |
| M-HLH Patients | Mean Serum Concentration of Total Bilirubin | 4.204 mg/dL | Standard Deviation 6.359 |
Primary
Mean Serum Concentration of White Blood Cells
Blood samples was collected at various times after HLH diagnosis to determine the concentration of white blood cells.
Time frame: 11 months
Population: The enrolled set included all patients who signed an informed consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-HLH Patients | Mean Serum Concentration of White Blood Cells | 4.263 cells*10^3/microliter (mcL) | Standard Deviation 3.48 |
| M-HLH Patients | Mean Serum Concentration of White Blood Cells | 2.459 cells*10^3/microliter (mcL) | Standard Deviation 2.854 |