Efficacy of Granulocyte Colony-stimulating Factor and Erythropoetin for Patients With Acute-on-chronic Liver Failure

PHASE3CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Acute on Chronic Hepatic Failure
Interventions
DRUG

Granulocyte Colony-stimulating Factor (G-CSF) and Erythropoetin (EPO)

G-CSF (in prefilled syringe) at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Darbopoetin alpha 100 mcg/ week (in prefilled syringe) for 4 weeks (total 4 doses).

DRUG

Placebo

Placebo 1 (in prefilled syringe) s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Placebo 2 every week (in prefilled syringe) for 4 weeks (total 4 doses).

Trial Locations (1)

110070

Institute of liver and Biliary Sciences, New Delhi

All Listed Sponsors
lead

Institute of Liver and Biliary Sciences, India

OTHER

NCT01383460 - Efficacy of Granulocyte Colony-stimulating Factor and Erythropoetin for Patients With Acute-on-chronic Liver Failure | Biotech Hunter | Biotech Hunter