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

NCT02642003 | Completed Phase 3

• 1 other identifier: Gastro-2014-OL
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Number of participants alive at 6 months

  6 months

Study Arms (2)

GCSF+SMT

EXPERIMENTAL

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

Drug: Granulocyte Colony Stimulating Factor

SMT

NO INTERVENTION

Interventions

Granulocyte Colony Stimulating Factor DRUG

GCSF+SMT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital

New Delhi, New Delhi, 110060, India

Location

Related Publications (1)

• 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.

  PMID: 27930386 DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co investigator

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 30, 2015
• Study Start: June 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-04

Locations

IN (1)