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NCT06047210

Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis

Completed Results posted Last updated 19 September 2024
What this trial tests

trial testing Blood Draws Data Collection in Hemophagocytic Lymphohistiocytoses in 14 participants. Completed in 30 October 2019.

Timeline
14 December 2016
Primary endpoint
30 October 2019
30 October 2019

Quick facts

Lead sponsorSwedish Orphan Biovitrum
StatusCompleted
Study typeOBSERVATIONAL
Enrollment14
Start date14 December 2016
Primary completion30 October 2019
Estimated completion30 October 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Swedish Orphan Biovitrum — full company profile →

Who can join

18 and older, any sex, with Hemophagocytic Lymphohistiocytoses. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) Primary · 11 months

Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10.

GroupValue95% CI
A-HLH Patients2079.286± 2659.228
M-HLH Patients15197.143± 21288.948
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9) Primary · 11 months

Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9.

GroupValue95% CI
A-HLH Patients4474.685± 10207.638
M-HLH Patients6602.853± 7777.846
Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg) Primary · 11 months

Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg.

GroupValue95% CI
A-HLH Patients81.782± 140.870
M-HLH Patients809.810± 769.433
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10) Primary · 11 months

Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10.

GroupValue95% CI
A-HLH Patients24.157± 87.640
M-HLH Patients266.948± 257.770
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B) Primary · 11 months

Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B.

GroupValue95% CI
A-HLH Patients2.140± 0.000
M-HLH Patients2.140± 0.000
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6) Primary · 11 months

Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6.

GroupValue95% CI
A-HLH Patients3.455± 3.727
M-HLH Patients29.695± 52.403
Mean Serum Concentration of Inflammatory Biomarker - Neopterin Primary · 11 months

Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin.

GroupValue95% CI
A-HLH Patients33.995± 29.227
M-HLH Patients839.775± 950.070
Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa) Primary · 11 months

Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa.

GroupValue95% CI
A-HLH Patients6.050± 6.405
M-HLH Patients14.308± 12.010
Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg) Primary · 11 months

Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg.

GroupValue95% CI
A-HLH Patients34.178± 25.950
M-HLH Patients1069.215± 1987.409
Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163) Primary · 11 months

Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163.

GroupValue95% CI
A-HLH Patients1431.488± 1078.058
M-HLH Patients878.880± NA
Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra) Primary · 11 months

Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra.

GroupValue95% CI
A-HLH Patients2273.193± 2383.154
M-HLH Patients27052.498± 24009.516
Mean Serum Concentration of White Blood Cells Primary · 11 months

Blood samples was collected at various times after HLH diagnosis to determine the concentration of white blood cells.

GroupValue95% CI
A-HLH Patients4.263± 3.480
M-HLH Patients2.459± 2.854

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Hemophagocytic Lymphohistiocytoses

Currently open trials in the same condition.

Other Swedish Orphan Biovitrum trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06047210.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing