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

Severe Alcoholic Hepatitis Clinical Trial

Official title:

Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis. - A Double Blind Randomized Control Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820208
• Other study ID #: ILBS- AH-01
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: November 11, 2017
• Start date: March 1, 2014
• Est. completion date: June 1, 2017

Study information

• Verified date: August 2016
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic
• Severe Alcoholic Hepatitis

Intervention

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

Locations

Country	Name	City	State
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Survival of subjects in both group		4 weeks and 12 weeks
Secondary	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.	4 weeks and 12 weeks
Secondary	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	4 weeks and 12 weeks