Skip to main content
OpenTrials
Completed

NCT Number: NCT02642003

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital

New Delhi, 110060, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Granulocyte Colony Stimulating Factor

Drug

Primary outcomes

  1. Number of participants alive at 6 months

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Sir Ganga Ram Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 30, 2015
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.