Granulocyte Colony Stimulating Factor Four Week Plus N-Acetyl Cysteine in Severe Alcoholic Hepatitis

PHASE4CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

October 1, 2017

Primary Completion Date

February 28, 2021

Study Completion Date

February 28, 2021

Conditions
Alcoholic Hepatitis
Interventions
DRUG

Standard Medical Therapy

Standard medical therapy involves primary treatment with normal hospital nutrition (1800 to 2000 kcal per day). Diuretics, sodium restriction and albumin for treatment of ascites or fresh frozen plasma for coagulopathy or antibiotics for any focus of infection as spontaneous bacterial peritonitis (SBP), pneumonia, cellulitis, and urinary tract infection as indicated.

DRUG

G-CSF

standard medical therapy plus G-CSF- 5μg/Kg s.c every 12 hours for 5 consecutive days

DRUG

G-CSF and NAC

Standard Medical Therapy plus G-CSF with intravenous NAC (day 1: NAC at 150, 50, and 100 mg/kg in 250, 500, and 1000 ml of 5% glucose solution over 30 minutes, 4 hours, and 16 hours, respectively; days 2 through 5: 100 mg/kg/day in 1000 ml of 5% glucose solution followed by oral NAC from days 6 to 28)

Trial Locations (1)

160012

Dept of Hepatology, PGIMER, Chandigarh

All Listed Sponsors
lead

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

NCT05840640 - Granulocyte Colony Stimulating Factor Four Week Plus N-Acetyl Cysteine in Severe Alcoholic Hepatitis | Biotech Hunter | Biotech Hunter