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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Postgraduate Institute of Medical Education and Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01341951
First received: April 15, 2011
Last updated: April 25, 2011
Last verified: January 2011
  Purpose

Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis


Condition Intervention
Liver Failure, Acute
Drug: Granulocyte colony stimulating factor

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: G-CSF in Acute Liver Failure and Alcoholic Hepatitis - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • • Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical and biochemical improvement in liver functions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G-CSF therapy in acute liver failure and alcoholic hepatitis
G-CSF therapy given in cases with acute liver failure and alcoholic hepatitis
Drug: Granulocyte colony stimulating factor
300 I.U twice daily for 5 days

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341951

Contacts
Contact: Arun Sharma, DM 08872721666 drarunvashisht@yahoo.co.in
Contact: Virendra Singh 09914209338 virendrasingh100@hotmail.com

Locations
India
Postgraduate Institute of Medical Education & Research Chandigarh India Recruiting
Chandigarh, India, 1600012
Contact: Arun Sharma, DM    08872721666    drarunvashisht@yahoo.co.in   
Sub-Investigator: Arun Sharma, DM Hepatology         
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: virendra singh Postgraduate Institute of Medical Education and Research Chandigarh India
Principal Investigator: virendra Singh Postgraduate Institute of Medical Education and Research Chandigarh India
  More Information

Publications:
Responsible Party: Dr. Virendra Singh, Postgraduate Institute of Medical Education and Research, Chandigarh, India
ClinicalTrials.gov Identifier: NCT01341951     History of Changes
Other Study ID Numbers: PIMERIndia
Study First Received: April 15, 2011
Last Updated: April 25, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
liver failure, Acute

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis
Hepatitis A
Liver Failure
Liver Failure, Acute
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Hepatic Insufficiency
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014