Drug-Induced Acute Liver Injury Clinical Trial
Official title:
Macrophage Activation, Assessed by Macrophage Markers Soluble CD163 and Soluble CD206, as Indication of Early Liver Cell Damage in Paracetamol Overdose
Paracetamol (PCM) is a widely used over-the-counter analgesic, and overdose with PCM is a
condition regularly seen in everyday clinical practice. Identification of the patients with
early signs of liver injury that may develop into acute liver failure is important. Previous
research has shown that macrophages play a role in the development of liver damage in
PCM-induced acute liver failure, making macrophage markers interesting possible biomarkers of
this condition. In the present study, the investigators aimed to investigate the extent and
timing of macrophage activation in PCM-induced liver injury by measuring levels of macrophage
markers sCD163 and sCD206 in patients admitted with PCM overdose. The investigators also
hoped to find out whether these markers are valuable as prognostic markers of severe outcome
in these patients.
Furthermore the investigators examined the possible effect of antidote treatment with
N-acetylcysteine on activation and function of macrophages by administering NAC to healthy
subjects and measuring levels of sCD163 and sCD206 prior to and after completion of
treatment.
The part of the study concerning the patients with PCM overdose was strictly observational
with measurement of macrophage markers and no other intervention than the NAC treatment
administered in the setting of management of the participants PCM overdose according to best
clinical practice.
The interventional part of the study which is submitted for registration here concerns only
healthy controls who were exposed to NAC treatment in order to assess the direct effects of
NAC on macrophages. The participants received NAC treatment according to the same protocol as
the PCM overdosed patients, and macrophage activation markers were measured prior to and
after 16 hours of NAC treatment. Thus, the involvement of the participants in the study was
limited to the 16 hours of NAC treatment.
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