search
Back to results

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

Primary Purpose

Cirrhosis

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Granulocyte Colony Stimulating Factor
Sponsored by
Sir Ganga Ram Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GCSF+SMT

SMT

Arm Description

5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months

Outcomes

Primary Outcome Measures

Number of participants alive at 6 months

Secondary Outcome Measures

Full Information

First Posted
December 21, 2015
Last Updated
October 15, 2016
Sponsor
Sir Ganga Ram Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02642003
Brief Title
To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis
Official Title
To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Ganga Ram Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
259 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GCSF+SMT
Arm Type
Experimental
Arm Description
5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months
Arm Title
SMT
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Granulocyte Colony Stimulating Factor
Primary Outcome Measure Information:
Title
Number of participants alive at 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
27930386
Citation
Prajapati R, Arora A, Sharma P, Bansal N, Singla V, Kumar A. Granulocyte colony-stimulating factor improves survival of patients with decompensated cirrhosis: a randomized-controlled trial. Eur J Gastroenterol Hepatol. 2017 Apr;29(4):448-455. doi: 10.1097/MEG.0000000000000801.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs