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

Not Applicable

• Conditions: Liver Failure, Acute
• Interventions: Drug: Granulocyte colony stimulating factor

• Registration Number: NCT01341951
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis

Detailed Description

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.

Study Timeline

• Study Start: 2010-06
• Status Verified: 2011-01
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-25
• Last Update Submitted: 2011-04-25
• Study First Posted: 2011-04-26
• Last Update Posted: 2011-04-26
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G-CSF therapy in acute liver failure and alcoholic hepatitis	Granulocyte colony stimulating factor	G-CSF therapy given in cases with acute liver failure and alcoholic hepatitis

Primary Outcome Measures

Name	Time	Method
• Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization	1 year

Secondary Outcome Measures

Name	Time	Method
clinical and biochemical improvement in liver functions	1 year

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education & Research Chandigarh India; 🇮🇳 Chandigarh, India