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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GCSF+SMT

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

Group Type EXPERIMENTAL

Granulocyte Colony Stimulating Factor

Intervention Type DRUG

SMT

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Granulocyte Colony Stimulating Factor

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No