Immune Cell Dysfunction in Severe Alcoholic Hepatitis
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|ClinicalTrials.gov Identifier: NCT02275195|
Recruitment Status : Recruiting
First Posted : October 27, 2014
Last Update Posted : February 5, 2019
|Condition or disease|
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|
|Estimated Enrollment :||50 participants|
|Official Title:||Immune Cell Dysfunction in Severe Alcoholic Hepatitis|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
- 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
- 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
- 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
- Change from baseline to end of study in cell cultures for patients with Alcoholic Hepatitis [ Time Frame: on average 4 weeks ]
Biospecimen Retention: Samples Without DNA
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): NCT02275195
|Contact: Carol L Alves, BSc, MRes||01268 529400 ext 3599||Carol.Alves@btuh.nhs.uk|
|Basildon and Thurrock University Hospitals NHS FT||Recruiting|
|Basildon, Essex, United Kingdom, SS16 5NL|
|Contact: Carol L Alves, BSc, MRes 01268 529400 ext 3599 Carol.Alves@btuh.nhs.uk|
|Principal Investigator: Gavin Wright, MBBS MRCP|
|Principal Investigator:||Gavin Wright, MBBS MRCP||Basildon and Thurrock University Hospitals NHS FT|