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Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03679442
Recruitment Status : Completed
First Posted : September 20, 2018
Last Update Posted : September 24, 2018
Sponsor:
Collaborators:
The Danish Council for Strategic Research
Novo Nordisk A/S
Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Drug-Induced Acute Liver Injury Drug: N-acetylcysteine Phase 1

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Macrophage Activation, Assessed by Macrophage Markers Soluble CD163 and Soluble CD206, as Indication of Early Liver Cell Damage in Paracetamol Overdose
Actual Study Start Date : September 8, 2014
Actual Primary Completion Date : June 14, 2015
Actual Study Completion Date : February 18, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy individuals
Healthy individuals received intravenous N-acetylcysteine (NAC) treatment to investigate its actions on macrophage activation assessed by the markers soluble CD163 and CD206
 Drug: N-acetylcysteine
Non-randomized exposure to N-acetylcysteine (NAC) of healthy individuals corresponding to the clinical treatment guidelines for paracetamol-overdosed patients
Other Names:
  • NAC
  • Paracetamol antidote
  • Acetylcysteine


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in sCD163 [ Time Frame: 16 hours ]
    Change in macrophage activation marker soluble CD163 after treatment of healthy individuals with N-acetylcysteine

  2. Change from baseline in sCD206 [ Time Frame: 16 hours ]
    Change in macrophage activation marker soluble CD206 after treatment of healthy individuals with N-acetylcysteine


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 to 75

Exclusion Criteria:

  • A history of previous illness
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679442


Sponsors and Collaborators
University of Aarhus
The Danish Council for Strategic Research
Novo Nordisk A/S
Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat
Investigators
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Principal Investigator: Henning Grønbæk Department of Hepatology and gastroenterology, Aarhus University Hospital
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03679442    
Other Study ID Numbers: PCMsCD163NAC
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
macrophage activation, N-acetylcysteine, acetaminophen
Additional relevant MeSH terms:
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Chemical and Drug Induced Liver Injury
Chemically-Induced Disorders
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Poisoning
Acetylcysteine
N-monoacetylcystine
Antidotes
 Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents