Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis

N/ACompletedNCT01820208

Institute of Liver and Biliary Sciences, India28 enrolled

Overview

After successful screening, first the investigators first treat patients of severe alcoholic hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's score \[\>0.45\] would be randomized into either placebo group or G-CSF group. Responders to steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non responders will be randomized to receive G-CSF for 28days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Severe Alcoholic Hepatitis

Interventions

G-CSFDRUG

G-CSF would be given at a dose of 5 microgram/kg daily for 5 days followed by once in 3 days for a total of 12 doses.

PlaceboDRUG

Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Severe alcoholic hepatitis patients \[Maddrey's score \> 32\] aged between 18 to 65 years. Exclusion Criteria: * Presence of active infections * Acute GI bleed * Hepatorenal syndrome * Patient unwilling * DF\>120 * Autoimmune hepatitis * Hepatitis B, Hepatitis C, HIV cases * Pregnancy

Locations (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Proportion of Survival of subjects in both group

Time frame: 4 weeks and 12 weeks

Secondary Outcomes

Improvement in Child's score in steroid unresponsive patients with severe alcoholic hepatitis patients

Change in child score at 4 week and 12 weeks compared to baseline in both groups.

Time frame: 4 weeks and 12 weeks

Improvement in MELD score in steroid unresponsive patients with severe alcoholic hepatitis patients

Change in MELD score at 4 week and 12 weeks compared to baseline in both groups

Time frame: 4 weeks and 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.