Immune Cell Dysfunction in Severe Alcoholic Hepatitis

NCT02275195 | Unknown

• 1 other identifier: B663
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis

Keywords

hepatitis; alcohol

Outcome Measures

Primary Outcomes (1)

• To determine and changes to immune cell responses for outpatients with Alcoholic Hepatitis

  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 Outcomes (3)

• Change from baseline to end of study in flow cytometry for patients with Alcoholic Hepatitis

  on average 4 weeks

• Change from baseline to end of study in real time PCR for patients with Alcoholic Hepatitis

  On average 4 weks

• Change from baseline to end of study in cell cultures for patients with Alcoholic Hepatitis

  on average 4 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age 18-65 years
• 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).
• Ongoing abuse of alcohol (drinking in excess of 28 units/wk)

You may not qualify if:

• Co-infection with HIV/Hepatitis B / Hepatitis C virus infection.
• Patients with autoimmune liver disease.
• Patients with metabolic liver disease.
• Patients with significant psychiatric and/or neurological co-morbidity.
• Hepatocellular carcinoma or other neoplastic disease
• Pregnancy or breast feeding of infants.

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead

Study Sites (1)

Basildon Hospital

Basildon, Essex, SS16 5NL, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Gavin Wright, MBBS MRCP

  Basildon and Thurrock University Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol L Alves, BSc, MRes

CONTACT

01268 529400; Carol.Alves@btuh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 27, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)