Immune Cell Dysfunction in Severe Alcoholic Hepatitis

January 11, 2024 updated by: Mid and South Essex NHS Foundation Trust
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Essex
      • Basildon, Essex, United Kingdom, SS16 5NL
        • Recruiting
        • Basildon Hospital
        • Contact:
        • Principal Investigator:
          • Gavin Wright, MBBS MRCP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients attending / being treated at the Basildon Hospital for acute severe alcoholic hepatitis will be identified as potential participants in these studies

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine and changes to immune cell responses for outpatients with Alcoholic Hepatitis
Time Frame: 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
Participants will be followed-up during thier hospital stay, which averages 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to end of study in flow cytometry for patients with Alcoholic Hepatitis
Time Frame: on average 4 weeks
Characterize the relationship between various elements of patients immune system and the progression of an episode of severe Alcoholic Hepatitis
on average 4 weeks
Change from baseline to end of study in real time PCR for patients with Alcoholic Hepatitis
Time Frame: On average 4 weks
Characterize the relationship between various elements of patients immune system and the progression of an episode of severe Alcoholic Hepatitis
On average 4 weks
Change from baseline to end of study in cell cultures for patients with Alcoholic Hepatitis
Time Frame: on average 4 weeks
Characterize the relationship between various elements of patients immune system and the progression of an episode of severe Alcoholic Hepatitis
on average 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mid and South Essex NHS Foundation Trust

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimated)

October 27, 2014

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B663

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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