Proteomic and transcriptomic analysis to understand the biology of alcoholic hepatitis

Not Applicable

• Conditions: Health Condition 1: K74- Fibrosis and cirrhosis of liver

• Registration Number: CTRI/2023/01/048844
• Lead Sponsor: ICMR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients age 18 to 80 years

2. Patients with probable or definite alcoholic hepatitis (AH) (as per AASLD guidelines)

will be enrolled from consecutive patients presenting first time to the department.

The diagnosis of AH will be made as per the NIAAA consensus, i.e.,

• onset of jaundice within the prior eight weeks,

• ongoing consumption of >40g (female) or >60 (male)g of alcohol/day for 6 months or

more, with less than 60 days of abstinence before the onset of jaundice

• aspartate aminotransferase >50, aspartate aminotransferase/alanine aminotransferase

>1.5, and both values <400IU/L

• serum bilirubin (total) >3.0 mg/dL

• liver biopsy confirmation in patients with confounding factors

Exclusion Criteria

Patients having:

i. HIV infection

ii. Prior organ transplantation

iii. Hepatic or extra-hepatic malignancy

iv. Receiving any experimental therapies

v. Pregnant or lactating women, will be excluded

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of GH along with standard medical therapy (SMT) as compared to SMT-alone on overall survival (Time frame 30 days)Timepoint: 30 days and 90 days

Secondary Outcome Measures

Name	Time	Method
Proteomic analysis of neutrophils towards unravelling parameters influencing the <br/ ><br>pathophysiology and outcomes in alcoholic hepatitis (AH) patients. [Time frame: day-0 and day-7]Timepoint: 0-16 months;Transcriptomic analysis of neutrophils to define molecular signatures linked to <br/ ><br>pathophysiology and outcomes in alcoholic hepatitis (AH) patients. [Time frame: day-0 and day-7]Timepoint: 0-16 months;Validation of identified transcriptomic and proteomic signatures associated with prognosis in <br/ ><br>alcoholic hepatitis (AH) patients. [Time frame: day-0 and day-7]Timepoint: 18-34 months