N/A
Completed N=14
Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis
Hemophagocytic Lymphohistiocytoses
Source: ClinicalTrials.gov NCT06047210 ↗
Enrolled (actual)
14
Serious AEs
—
Results posted
Sep 2024
Primary outcomePrimary: Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) — 2079.286; 15197.143 picogram/milliliter (pg/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) |
2079.286; 15197.143 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9) |
4474.685; 6602.853 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg) |
81.782; 809.810 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10) |
24.157; 266.948 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B) |
2.140; 2.140 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6) |
3.455; 29.695 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Neopterin |
33.995; 839.775 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa) |
6.050; 14.308 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg) |
34.178; 1069.215 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163) |
1431.488; 878.880 | — |
| PRIMARY Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra) |
2273.193; 27052.498 | — |
| PRIMARY Mean Serum Concentration of White Blood Cells |
4.263; 2.459 | — |
| PRIMARY Mean Serum Concentration of Red Blood Cells |
3.420; 3.206 | — |
| PRIMARY Mean Serum Concentration of Hemoglobin |
10.11; 9.83 | — |
| PRIMARY Mean Serum Concentration of Hematocrit |
30.03; 28.55 | — |
| PRIMARY Mean Serum Concentration of Platelets |
182.6; 92.9 | — |
| PRIMARY Mean Serum Concentration of Neutrophils |
7.715; 22.303 | — |
| PRIMARY Mean Serum Concentration of Lymphocytes |
3.636; 1.956 | — |
| PRIMARY Mean Serum Concentration of Monocytes |
1.306; 0.948 | — |
| PRIMARY Mean Serum Concentration of Eosinophils |
0.252; 1.002 | — |
| PRIMARY Mean Serum Concentration of Basophils |
0.181; 0.222 | — |
| PRIMARY Mean Plasma Concentration of D-Dimer |
2300.0 | — |
| PRIMARY Mean Plasma Concentration of Fibrinogen |
306.8; 172.5 | — |
| PRIMARY Mean Activated Partial Thromboplastin Time (aPTT) |
27.98 | — |
| PRIMARY Mean Prothrombin Time |
13.81; 16.75 | — |
| PRIMARY Mean Serum Concentration of C-Reactive Protein |
27.97; 13.35 | — |
| PRIMARY Mean Serum Concentration of Ferritin |
5050.2273; 24331.4517 | — |
| PRIMARY Mean Plasma Concentration of Blood Urea Nitrogen |
17.3; 50.2 | — |
| PRIMARY Mean Serum Concentration of Creatinine |
0.768; 1.449 | — |
| PRIMARY Mean Serum Concentration of Albumin |
3.68; 3.21 | — |
| PRIMARY Mean Serum Concentration of Sodium |
136.4; 135.3 | — |
| PRIMARY Mean Serum Concentration of Fasting Triglycerides |
645.0 | — |
| PRIMARY Mean Serum Concentration of Total Bilirubin |
0.590; 4.204 | — |
| PRIMARY Mean Serum Concentration of Conjugated Bilirubin |
0.25; 12.80 | — |
| PRIMARY Mean Serum Concentration of Alanine Aminotransferase |
93.2; 54.8 | — |
| PRIMARY Mean Serum Concentration of Aspartate Aminotransferase |
66.0; 48.6 | — |
| PRIMARY Mean Serum Concentration of Alkaline Phosphatase |
121.1; 258.2 | — |
| PRIMARY Mean Serum Concentration of Lactate Dehydrogenase |
539.8; 362.7 | — |
| PRIMARY Mean Serum Concentration of Immunoglobulin G (IgG) |
763.6; 996.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06047210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.