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

Liver Failure, Acute Clinical Trial

— G-CSF  

Official title:

G-CSF in Acute Liver Failure and Alcoholic Hepatitis - A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01341951
• Other study ID #: PIMERIndia
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2011
• Last updated: April 25, 2011
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2011
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Arun Sharma, DM
• Phone: 08872721666
• Email: drarunvashisht[@]yahoo.co.in
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis, Alcoholic
• Liver Failure
• Liver Failure, Acute

Intervention

Drug:
• Granulocyte colony stimulating factor
300 I.U twice daily for 5 days

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education & Research Chandigarh India	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization		1 year	No
Secondary	clinical and biochemical improvement in liver functions		1 year	Yes