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

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ClinicalTrials.gov Identifier: NCT02642003
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Ashish Kumar, 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.


Condition or disease Intervention/treatment Phase
Cirrhosis Drug: Granulocyte Colony Stimulating Factor Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis
Study Start Date : June 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: GCSF+SMT
5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months
Drug: Granulocyte Colony Stimulating Factor
No Intervention: SMT



Primary Outcome Measures :
  1. Number of participants alive at 6 months [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642003


Locations
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India
Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
New Delhi, India, 110060
Sponsors and Collaborators
Sir Ganga Ram Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Ashish Kumar, Co investigator, Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier: NCT02642003     History of Changes
Other Study ID Numbers: Gastro-2014-OL
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Sargramostim
Lenograstim
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic