To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis

Sir Ganga Ram Hospital

Status and phase

Completed

Phase 3

Conditions

Cirrhosis

Treatments

Drug: Granulocyte Colony Stimulating Factor

Study type

Interventional

Funder types

Other

Identifiers

NCT02642003

Gastro-2014-OL

Details and patient eligibility

About

Background and Aims: Liver transplantation is the only curative treatment modality for decompensated cirrhosis and is limited by donor organ availability and financial resources; thus many patients die while awaiting liver transplant. Granulocyte colony stimulating factor (GCSF) therapy can mobilize bone marrow stem cells for tissue regeneration, and has been shown to benefit patients with liver disease. The investigators evaluated the efficacy of GCSF therapy in decompensated cirrhosis in an open labelled randomized control trial.

Patients and Methods: Consecutive patients with decompensated cirrhosis of mixed etiologies were randomized to receive either a 5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months (Group-A); or standard medical therapy alone for 6 months (Group-B). At the end of 6 months their survival were compared.

Enrollment

259 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years to75 years
Patients of decompensated cirrhosis with CTP ≥6 and ≤ 13
Liver transplantation not feasible soon (due to financial reasons or unavailability of donors).

Exclusion criteria

Hepatocellular Carcinoma
Sepsis (Any culture positive: blood, urine, any other obvious source of infection: UTI, SBP): Patients were included after sepsis is controlled.
Any organ failure
Grade 3 or 4 Hepatic Encephalopathy, Active Variceal bleed, Hepatorenal Syndrome: Patients might be included after clinical improvement
HIV seropositivity
Pregnancy
Refusal to participate in the study
Previous known hypersensitivity to G-CSF