Clinical trial NCT02275195: Immune Cell Dysfunction in Severe Alcoholic Hepatitis
Official title: Immune Cell Dysfunction in Severe Alcoholic Hepatitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis
Keywords: hepatitis
alcohol
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine and changes to immune cell responses for outpatients with Alcoholic Hepatitis
timeFrame: Participants will be followed-up during thier hospital stay, which averages 4 weeks
Secondary outcomes:
measure: Change from baseline to end of study in flow cytometry for patients with Alcoholic Hepatitis
timeFrame: on average 4 weeks
measure: Change from baseline to end of study in real time PCR for patients with Alcoholic Hepatitis
timeFrame: On average 4 weks
measure: Change from baseline to end of study in cell cultures for patients with Alcoholic Hepatitis
timeFrame: on average 4 weeks
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Basildon Hospital
state: Essex
Study officials:
affiliation: Basildon and Thurrock University Hospitals NHS FT
name: Gavin Wright, MBBS MRCP
role: PRINCIPAL_INVESTIGATOR
References: