Investigating immune cell changes in severe alcoholic hepatitis
Immune Cell Dysfunction in Severe Alcoholic Hepatitis
This study looks at how changes in immune cells affect the health of people with severe alcoholic hepatitis to see if it can help improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Mid and South Essex NHS Foundation Trust Academic / other |
| Locations | 1 site (Basildon, Essex) |
| Trial ID | NCT02275195 on ClinicalTrials.gov |
What this trial studies
This observational study examines how the frequency and function of immune cells in patients with severe alcoholic hepatitis affect their health outcomes. By collecting blood samples, researchers will analyze the immune system's response and how it relates to the severity of the condition. The study aims to understand the impact of established treatment strategies on these immune cell subsets, potentially leading to improved treatment approaches for alcoholic hepatitis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with severe alcoholic hepatitis and ongoing alcohol abuse.
Not a fit: Patients with co-infections, autoimmune liver disease, or significant psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for patients suffering from severe alcoholic hepatitis.
How similar studies have performed: While this study explores a specific aspect of immune response in alcoholic hepatitis, similar studies have shown promise in understanding immune dysfunction in liver diseases.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Basildon, Essex
- Basildon Hospital — Basildon, Essex, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Gavin Wright, MBBS MRCP — Basildon and Thurrock University Hospitals NHS FT
- Study coordinator: Carol L Alves, BSc, MRes
- Email: Carol.Alves@btuh.nhs.uk
- Phone: 01268 529400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.