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Immune Cell Dysfunction in Severe Alcoholic Hepatitis

Sponsor
Mid and South Essex NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT02275195
Collaborator
(none)
50
Enrollment
1
Location
109
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Through bio-sampling this study investigates the relationship between the frequency and function of the cells of a patients immune system and how these change and impact on the outcome of alcoholic hepatitis. the investigators will examine the role of different cells of the immune system and how they may determine the outcome of this condition. The investigators will also look at how established treatment strategies impact on the frequency and function of these cell subsets.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Through bio-sampling this study investigates the relationship between the frequency and function of the cells of a patients immune system and how these change and impact on the outcome of alcoholic hepatitis. The investigators will examine the role of different cells of the immune system and how they may determine the outcome of this condition. The investigators will also look at how established treatment strategies impact on the frequency and function of these cell subsets.

    Alcohol is the most common cause of liver disease in the developed world and results in the death of 2.5 million people annually. It is a causal factor in more than 60 major types of diseases and injuries and approximately 4.5% of the global burden of disease and injury is attributable to alcohol. Acute alcoholic hepatitis (AAH) is perhaps the most florid form of ALD and the leading cause of mortality in these patients is the development of sepsis which occurs in up to 40% of these patients and has a mortality rate of 50%.

    By gaining a better understanding of the relationship between elements of the immune system and the progression to severe alcoholic hepatitis, it will allow the formulation of more effective treatment strategies for this condition.

    Patients who agree to participate in this study will have an extra 40mls of blood drawn for scientific studies at the same time as routine blood samples are taken as part of their ongoing care.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Immune Cell Dysfunction in Severe Alcoholic Hepatitis
    Study Start Date :
    Nov 1, 2013
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. To determine and changes to immune cell responses for outpatients with Alcoholic Hepatitis [Participants will be followed-up during thier hospital stay, which averages 4 weeks]

      Characterize the relationship between various elements of patients immune system and the progression of an episode of severe Alcoholic Hepatitis

    Secondary Outcome Measures

    1. Change from baseline to end of study in flow cytometry for patients with Alcoholic Hepatitis [on average 4 weeks]

      Characterize the relationship between various elements of patients immune system and the progression of an episode of severe Alcoholic Hepatitis

    2. Change from baseline to end of study in real time PCR for patients with Alcoholic Hepatitis [On average 4 weks]

      Characterize the relationship between various elements of patients immune system and the progression of an episode of severe Alcoholic Hepatitis

    3. Change from baseline to end of study in cell cultures for patients with Alcoholic Hepatitis [on average 4 weeks]

      Characterize the relationship between various elements of patients immune system and the progression of an episode of severe Alcoholic Hepatitis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age 18-65 years

    2. Patients presented with severe alcoholic hepatitis with a Maddrey score (discriminant function) of >32 (The Maddrey score uses various blood results on a patient to define the severity of alcoholic hepatitis e.g.bilirubin etc).

    3. Ongoing abuse of alcohol (drinking in excess of 28 units/wk)

    Exclusion Criteria:

    1. Co-infection with HIV/Hepatitis B / Hepatitis C virus infection.

    2. Patients with autoimmune liver disease.

    3. Patients with metabolic liver disease.

    4. Patients with significant psychiatric and/or neurological co-morbidity.

    5. Hepatocellular carcinoma or other neoplastic disease

    6. Pregnancy or breast feeding of infants.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Basildon Hospital Basildon Essex United Kingdom SS16 5NL

    Sponsors and Collaborators

    • Mid and South Essex NHS Foundation Trust

    Investigators

    • Principal Investigator: Gavin Wright, MBBS MRCP, Basildon and Thurrock University Hospitals NHS FT

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mid and South Essex NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT02275195
    Other Study ID Numbers:
    • B663
    First Posted:
    Oct 27, 2014
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Mid and South Essex NHS Foundation Trust
    hepatitis
    alcohol
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis
    Hepatitis, Alcoholic

    Study Results

    No Results Posted as of Apr 6, 2022