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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Severe Alcoholic Hepatitis

Treatments: Drug: G-CSF; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01820208

ILBS- AH-01

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

28 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: G-CSF

G-CSF

Experimental group

Description:

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.

Treatment:

Drug: Placebo