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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642003
• Other study ID #: Gastro-2014-OL
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2015
• Last updated: October 15, 2016
• Start date: June 2014
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Sir Ganga Ram Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• Granulocyte Colony Stimulating Factor

Locations

Country	Name	City	State
India	Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Sir Ganga Ram Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants alive at 6 months		6 months	No