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

Not Applicable

Completed

• Conditions: Severe Alcoholic Hepatitis
• Interventions: Drug: Placebo; Drug: G-CSF

• Registration Number: NCT01820208
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-28
• Study Start: 2014-03-01
• Status Verified: 2016-08
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Last Update Submitted: 2017-11-11
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G-CSF	Placebo	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.
Placebo	G-CSF	Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses)

Primary Outcome Measures

Name	Time	Method
Proportion of Survival of subjects in both group	4 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in Child's score in steroid unresponsive patients with severe alcoholic hepatitis patients	4 weeks and 12 weeks	Change in child score at 4 week and 12 weeks compared to baseline in both groups.
Improvement in MELD score in steroid unresponsive patients with severe alcoholic hepatitis patients	4 weeks and 12 weeks	Change in MELD score at 4 week and 12 weeks compared to baseline in both groups

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India