Granulocyte Colony Stimulating Factor (G-CSF) in Acute Liver Failure and Alcoholic Hepatitis

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-06-30

Brief Summary

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Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis

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Detailed Description

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In this study 4 groups have been taken. Two groups of cases including Alcoholic patients and acute liver failure which are given G-CSF therapy and two groups of controls given standard therapy. Primary end point is to see the mobilization of CD-34 hematopoietic cells and survival. Secondary end point is to see the clinical and biochemical improvement in liver functions.

Conditions

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Liver Failure, Acute

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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G-CSF therapy in acute liver failure and alcoholic hepatitis

G-CSF therapy given in cases with acute liver failure and alcoholic hepatitis

Group Type EXPERIMENTAL

Granulocyte colony stimulating factor

Intervention Type DRUG

300 I.U twice daily for 5 days

Interventions

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Granulocyte colony stimulating factor

300 I.U twice daily for 5 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with Acute Liver failure as defined by AASLD.65
* Patients with Alcoholic hepatitis defined as follows: decades of heavy alcohol use (mean intake, approximately 100 g per day).The combination of an aspartate aminotransferase level that is elevated (but \<300 IU per milliliter) and a ratio of the aspartate aminotransferase level to the alanine aminotransferase level that is more than 2, a total serum bilirubin level of more than 5 mg per deciliter (86 μmol per liter), an elevated INR, and neutrophilia.

Exclusion Criteria

• Known hypersensitivity to filgrastim

* creatinine \> 150 µmol/L
* infection or hemorrhage within the last 10 days
* documented hepatocellular carcinoma
* hepatitis B,C or human immunodeficiency virus seropositivity and pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No