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

Phase 3

Completed

• Conditions: Cirrhosis
• Interventions: Drug: Granulocyte Colony Stimulating Factor

• Registration Number: NCT02642003
• Lead Sponsor: Sir Ganga Ram Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-30
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-10-15
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GCSF+SMT	Granulocyte Colony Stimulating Factor	5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months

Primary Outcome Measures

Name	Time	Method
Number of participants alive at 6 months	6 months

Trial Locations

Locations (1)

Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital; 🇮🇳 New Delhi, India