G-CSF and Erythropoetin in Survival of Patients With Decompensated Liver Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

March 31, 2013

Conditions
Chronic Liver Disease
Interventions
DRUG

G-CSF+EPO

"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).~Arms: G-CSF+EPO 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)."

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

NCT01384565 - G-CSF and Erythropoetin in Survival of Patients With Decompensated Liver Disease | Biotech Hunter | Biotech Hunter