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

Primary Purpose

Liver Failure, Acute

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Granulocyte colony stimulating factor
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Failure, Acute focused on measuring liver failure, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Postgraduate Institute of Medical Education & Research Chandigarh IndiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

G-CSF therapy in acute liver failure and alcoholic hepatitis

Arm Description

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

Outcomes

Primary Outcome Measures

• Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization

Secondary Outcome Measures

clinical and biochemical improvement in liver functions

Full Information

First Posted
April 15, 2011
Last Updated
April 25, 2011
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01341951
Brief Title
Granulocyte Colony Stimulating Factor (G-CSF) in Acute Liver Failure and Alcoholic Hepatitis
Acronym
G-CSF
Official Title
G-CSF in Acute Liver Failure and Alcoholic Hepatitis - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure, Acute
Keywords
liver failure, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
G-CSF therapy in acute liver failure and alcoholic hepatitis
Arm Type
Experimental
Arm Description
G-CSF therapy given in cases with acute liver failure and alcoholic hepatitis
Intervention Type
Drug
Intervention Name(s)
Granulocyte colony stimulating factor
Intervention Description
300 I.U twice daily for 5 days
Primary Outcome Measure Information:
Title
• Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
clinical and biochemical improvement in liver functions
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arun Sharma, DM
Phone
08872721666
Email
drarunvashisht@yahoo.co.in
First Name & Middle Initial & Last Name or Official Title & Degree
Virendra Singh
Phone
09914209338
Email
virendrasingh100@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
virendra singh
Organizational Affiliation
Postgraduate Institute of Medical Education and Research Chandigarh India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Postgraduate Institute of Medical Education & Research Chandigarh India
City
Chandigarh
ZIP/Postal Code
1600012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arun Sharma, DM
Phone
08872721666
Email
drarunvashisht@yahoo.co.in
First Name & Middle Initial & Last Name & Degree
Arun Sharma, DM Hepatology

12. IPD Sharing Statement

Citations:
PubMed Identifier
18537187
Citation
Spahr L, Lambert JF, Rubbia-Brandt L, Chalandon Y, Frossard JL, Giostra E, Hadengue A. Granulocyte-colony stimulating factor induces proliferation of hepatic progenitors in alcoholic steatohepatitis: a randomized trial. Hepatology. 2008 Jul;48(1):221-9. doi: 10.1002/hep.22317.
Results Reference
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Granulocyte Colony Stimulating Factor (G-CSF) in Acute Liver Failure and Alcoholic Hepatitis

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