Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immune Cell Dysfunction in Severe Alcoholic Hepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02275195
Recruitment Status : Recruiting
First Posted : October 27, 2014
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Basildon and Thurrock University Hospitals NHS Foundation Trust

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
Hepatitis

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Carol L Alves, BSc, MRes 01268 529400 ext 3599 Carol.Alves@btuh.nhs.uk

Locations
Layout table for location information
United Kingdom
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         
Sponsors and Collaborators
Basildon and Thurrock University Hospitals NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Gavin Wright, MBBS MRCP Basildon and Thurrock University Hospitals NHS FT

Layout table for additonal information
Responsible Party: Basildon and Thurrock University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02275195     History of Changes
Other Study ID Numbers: B663
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Basildon and Thurrock University Hospitals NHS Foundation Trust:
hepatitis
alcohol
Additional relevant MeSH terms:
Layout table for MeSH terms
Virus Diseases
RNA Virus Infections
Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders