NCT01820208

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Alcoholic Hepatitis

Interventions

Type	Name	Description
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.
DRUG	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)

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2013-03-28
• Last updated: 2017-11-14

Locations

1 site across 1 country: India