Trial Outcomes & Findings for Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis (NCT NCT06047210)
NCT ID: NCT06047210
Last Updated: 2024-09-19
Results Overview
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10.
COMPLETED
14 participants
11 months
2024-09-19
Participant Flow
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.
A total of 14 patients were enrolled in the study.
Participant milestones
| Measure |
A-HLH Patients
Patients diagnosed with A-HLH.
|
Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) Patients
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
4
|
|
Overall Study
COMPLETED
|
10
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis
Baseline characteristics by cohort
| Measure |
A-HLH Patients
n=10 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 12.4 • n=99 Participants
|
54.3 years
STANDARD_DEVIATION 4.9 • n=107 Participants
|
47.5 years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African descent
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed/multi-racial
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)
|
2079.286 picogram/milliliter (pg/mL)
Standard Deviation 2659.228
|
15197.143 picogram/milliliter (pg/mL)
Standard Deviation 21288.948
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9)
|
4474.685 pg/mL
Standard Deviation 10207.638
|
6602.853 pg/mL
Standard Deviation 7777.846
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg)
|
81.782 pg/mL
Standard Deviation 140.870
|
809.810 pg/mL
Standard Deviation 769.433
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10)
|
24.157 pg/mL
Standard Deviation 87.640
|
266.948 pg/mL
Standard Deviation 257.770
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B)
|
2.140 pg/mL
Standard Deviation 0.000
|
2.140 pg/mL
Standard Deviation 0.000
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6)
|
3.455 pg/mL
Standard Deviation 3.727
|
29.695 pg/mL
Standard Deviation 52.403
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Inflammatory Biomarker - Neopterin
|
33.995 nanomoles
Standard Deviation 29.227
|
839.775 nanomoles
Standard Deviation 950.070
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa)
|
6.050 pg/mL
Standard Deviation 6.405
|
14.308 pg/mL
Standard Deviation 12.010
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg)
|
34.178 pg/mL
Standard Deviation 25.950
|
1069.215 pg/mL
Standard Deviation 1987.409
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163.
Outcome measures
| Measure |
A-HLH Patients
n=4 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=1 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163)
|
1431.488 nanogram (ng)/mL
Standard Deviation 1078.058
|
878.880 nanogram (ng)/mL
Standard Deviation NA
Standard deviation could not be determined when only 1 patient analyzed.
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra)
|
2273.193 pg/mL
Standard Deviation 2383.154
|
27052.498 pg/mL
Standard Deviation 24009.516
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of white blood cells.
Outcome measures
| Measure |
A-HLH Patients
n=10 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of White Blood Cells
|
4.263 cells*10^3/microliter (mcL)
Standard Deviation 3.480
|
2.459 cells*10^3/microliter (mcL)
Standard Deviation 2.854
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of red blood cells.
Outcome measures
| Measure |
A-HLH Patients
n=10 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Red Blood Cells
|
3.420 cells*10^6/mcL
Standard Deviation 0.745
|
3.206 cells*10^6/mcL
Standard Deviation 0.396
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin.
Outcome measures
| Measure |
A-HLH Patients
n=10 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Hemoglobin
|
10.11 gram/deciliter (g/dL)
Standard Deviation 1.93
|
9.83 gram/deciliter (g/dL)
Standard Deviation 1.09
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit.
Outcome measures
| Measure |
A-HLH Patients
n=10 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Hematocrit
|
30.03 percentage of volume of red cells
Standard Deviation 5.75
|
28.55 percentage of volume of red cells
Standard Deviation 3.55
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets.
Outcome measures
| Measure |
A-HLH Patients
n=10 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Platelets
|
182.6 cells*10^3/mcL
Standard Deviation 138.2
|
92.9 cells*10^3/mcL
Standard Deviation 87.1
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils.
Outcome measures
| Measure |
A-HLH Patients
n=10 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Neutrophils
|
7.715 cells*10^3/mcL
Standard Deviation 14.003
|
22.303 cells*10^3/mcL
Standard Deviation 37.944
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes.
Outcome measures
| Measure |
A-HLH Patients
n=10 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Lymphocytes
|
3.636 cells*10^3/mcL
Standard Deviation 10.880
|
1.956 cells*10^3/mcL
Standard Deviation 3.424
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes.
Outcome measures
| Measure |
A-HLH Patients
n=10 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Monocytes
|
1.306 cells*10^3/mcL
Standard Deviation 3.602
|
0.948 cells*10^3/mcL
Standard Deviation 1.721
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Eosinophils
|
0.252 cells*10^3/mcL
Standard Deviation 0.707
|
1.002 cells*10^3/mcL
Standard Deviation 2.449
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Basophils
|
0.181 cells*10^3/mcL
Standard Deviation 0.516
|
0.222 cells*10^3/mcL
Standard Deviation 0.399
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer.
Outcome measures
| Measure |
A-HLH Patients
n=1 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Plasma Concentration of D-Dimer
|
2300.0 microgram (mcg)/mL
Standard Deviation NA
Standard deviation could not be determined when only 1 patient analyzed.
|
—
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen.
Outcome measures
| Measure |
A-HLH Patients
n=4 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Plasma Concentration of Fibrinogen
|
306.8 milligram (mg)/dL
Standard Deviation 145.7
|
172.5 milligram (mg)/dL
Standard Deviation 83.0
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the aPTT.
Outcome measures
| Measure |
A-HLH Patients
n=3 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Activated Partial Thromboplastin Time (aPTT)
|
27.98 seconds
Standard Deviation 8.21
|
—
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the prothrombin time.
Outcome measures
| Measure |
A-HLH Patients
n=6 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=3 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Prothrombin Time
|
13.81 seconds
Standard Deviation 0.90
|
16.75 seconds
Standard Deviation 4.60
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of c-reactive protein.
Outcome measures
| Measure |
A-HLH Patients
n=5 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=3 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of C-Reactive Protein
|
27.97 mg/dL
Standard Deviation 31.13
|
13.35 mg/dL
Standard Deviation 12.06
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of ferritin.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=3 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Ferritin
|
5050.2273 ng/mL
Standard Deviation 5302.9183
|
24331.4517 ng/mL
Standard Deviation 38189.6158
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of blood urea nitrogen.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Plasma Concentration of Blood Urea Nitrogen
|
17.3 mg/dL
Standard Deviation 8.3
|
50.2 mg/dL
Standard Deviation 37.3
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Creatinine
|
0.768 mg/dL
Standard Deviation 0.293
|
1.449 mg/dL
Standard Deviation 0.748
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Albumin
|
3.68 gram/dL
Standard Deviation 0.55
|
3.21 gram/dL
Standard Deviation 0.87
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Sodium
|
136.4 millimoles/L
Standard Deviation 3.7
|
135.3 millimoles/L
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fasting triglycerides.
Outcome measures
| Measure |
A-HLH Patients
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=1 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Fasting Triglycerides
|
—
|
645.0 mg/dL
Standard Deviation NA
Standard deviation could not be determined when only 1 patient analyzed.
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of total bilirubin.
Outcome measures
| Measure |
A-HLH Patients
n=10 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Total Bilirubin
|
0.590 mg/dL
Standard Deviation 0.559
|
4.204 mg/dL
Standard Deviation 6.359
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of conjugated bilirubin.
Outcome measures
| Measure |
A-HLH Patients
n=8 Samples
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Samples
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Conjugated Bilirubin
|
0.25 mg/dL
Standard Deviation 0.31
|
12.80 mg/dL
Standard Deviation 1.13
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alanine aminotransferase.
Outcome measures
| Measure |
A-HLH Patients
n=10 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Alanine Aminotransferase
|
93.2 international units (IU)/L
Standard Deviation 145.6
|
54.8 international units (IU)/L
Standard Deviation 35.1
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of aspartate aminotransferase.
Outcome measures
| Measure |
A-HLH Patients
n=10 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=4 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Aspartate Aminotransferase
|
66.0 IU/L
Standard Deviation 105.8
|
48.6 IU/L
Standard Deviation 35.4
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alkaline phosphatase.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=2 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Alkaline Phosphatase
|
121.1 IU/L
Standard Deviation 98.8
|
258.2 IU/L
Standard Deviation 188.5
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lactate dehydrogenase.
Outcome measures
| Measure |
A-HLH Patients
n=9 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=3 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Lactate Dehydrogenase
|
539.8 IU/L
Standard Deviation 660.8
|
362.7 IU/L
Standard Deviation 274.4
|
PRIMARY outcome
Timeframe: 11 monthsPopulation: The enrolled set included all patients who signed an informed consent. Only patients with data collected for this outcome measure are reported.
Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG.
Outcome measures
| Measure |
A-HLH Patients
n=5 Participants
Patients diagnosed with A-HLH.
|
M-HLH Patients
n=1 Participants
Patients diagnosed with HLH in the context of a malignancy.
|
|---|---|---|
|
Mean Serum Concentration of Immunoglobulin G (IgG)
|
763.6 mg/dL
Standard Deviation 579.3
|
996.0 mg/dL
Standard Deviation NA
Standard deviation could not be determined when only 1 patient analyzed.
|
Adverse Events
A-HLH Patients
M-HLH Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place