Treatment of Macrophage Activation Syndrome (MAS) With Anakinra (NCT02780583) | Clinical Trial Compass
TerminatedPhase 1
Treatment of Macrophage Activation Syndrome (MAS) With Anakinra
Stopped: no further funding to continue, investigator relocated, no replacement found to continue
United States9 participantsStarted 2016-05-15
Plain-language summary
The primary purpose of this study is to determine whether giving injections of anakinra is a safe and well tolerated treatment to give as an adjunct to standard prescribed treatment for patients who are admitted to the hospital with signs of severe inflammation (macrophage activation syndrome) that is potentially life-threatening. Anakinra is a commercially available product (Kineretâ„¢) approved for the treatment of rheumatoid arthritis; it is a replica of a naturally occurring protein called Il-1 receptor antagonist (IL-1ra), made by humans to inhibit and regulate the action of interleukin-1 (IL-1). IL-1 is a mediator of inflammation that when generated in excess amounts by immune system cells can result in severe dysfunction of multiple organs that can be life-threatening. The specific primary objectives of the study are to determine if giving anakinra results in no increased infection complications or mortality. Additional data will be collected to determine whether anakinra administration results in any other unanticipated side effects in this setting, and the effects of anakinra administration on inflammation markers, the overall dose of steroids required to treat the inflammation, and the length of hospital stay.
Who can participate
Age range1 Year
SexALL
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Inclusion criteria
✓. Decreased platelet count (≤262 × 109/L)
✓. Elevated levels of aspartate aminotransferase (\>59 U/L)
✓. Decreased white blood cell count (≤4.0 × 109/L)
✓. Hypofibrinogenemia (≤2.5 g/L)
✓. Central nervous system dysfunction (irritability, disorientation, lethargy, seizures, coma)
✓. Hepatomegaly (≥3 cm below the costal margin or confirmed by imaging)
✓. Bicytopenia with two of the following:
Exclusion criteria
✕. Evidence of malignancy
✕. Culture evidence of systemic bacterial infection at the time of screening
✕. Known EBV viremia by PCR at time of screening (positive serologies are not an exclusion; results of EBV testing will not be necessary for enrollment, but may be ordered as part of the standard of care assessment to guide future management as results become available)
What they're measuring
1
Number of acquired infections, deaths in treatment group vs placebo group