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

Primary Purpose

Drug-Induced Acute Liver Injury

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Drug-Induced Acute Liver Injury focused on measuring macrophage activation, N-acetylcysteine, acetaminophen

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 to 75

Exclusion Criteria:

  • A history of previous illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Healthy individuals

    Arm Description

    Healthy individuals received intravenous N-acetylcysteine (NAC) treatment to investigate its actions on macrophage activation assessed by the markers soluble CD163 and CD206

    Outcomes

    Primary Outcome Measures

    Change from baseline in sCD163
    Change in macrophage activation marker soluble CD163 after treatment of healthy individuals with N-acetylcysteine
    Change from baseline in sCD206
    Change in macrophage activation marker soluble CD206 after treatment of healthy individuals with N-acetylcysteine

    Secondary Outcome Measures

    Full Information

    First Posted
    September 17, 2018
    Last Updated
    September 20, 2018
    Sponsor
    University of Aarhus
    Collaborators
    The Danish Council for Strategic Research, Novo Nordisk A/S, Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03679442
    Brief Title
    Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose
    Official Title
    Macrophage Activation, Assessed by Macrophage Markers Soluble CD163 and Soluble CD206, as Indication of Early Liver Cell Damage in Paracetamol Overdose
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 8, 2014 (Actual)
    Primary Completion Date
    June 14, 2015 (Actual)
    Study Completion Date
    February 18, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus
    Collaborators
    The Danish Council for Strategic Research, Novo Nordisk A/S, Savværksejer Jeppe Juhl og Hustru Ovita Juhls mindelegat

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Drug-Induced Acute Liver Injury
    Keywords
    macrophage activation, N-acetylcysteine, acetaminophen

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy individuals
    Arm Type
    Experimental
    Arm Description
    Healthy individuals received intravenous N-acetylcysteine (NAC) treatment to investigate its actions on macrophage activation assessed by the markers soluble CD163 and CD206
    Intervention Type
    Drug
    Intervention Name(s)
    N-acetylcysteine
    Other Intervention Name(s)
    NAC, Paracetamol antidote, Acetylcysteine
    Intervention Description
    Non-randomized exposure to N-acetylcysteine (NAC) of healthy individuals corresponding to the clinical treatment guidelines for paracetamol-overdosed patients
    Primary Outcome Measure Information:
    Title
    Change from baseline in sCD163
    Description
    Change in macrophage activation marker soluble CD163 after treatment of healthy individuals with N-acetylcysteine
    Time Frame
    16 hours
    Title
    Change from baseline in sCD206
    Description
    Change in macrophage activation marker soluble CD206 after treatment of healthy individuals with N-acetylcysteine
    Time Frame
    16 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 18 to 75 Exclusion Criteria: A history of previous illness
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Henning Grønbæk
    Organizational Affiliation
    Department of Hepatology and gastroenterology, Aarhus University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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