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

P

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Unknown

Conditions

Liver Failure, Acute

Treatments

Drug: Granulocyte colony stimulating factor

Study type

Interventional

Funder types

Other

Identifiers

NCT01341951
PIMERIndia

Details and patient eligibility

About

Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 1 patient group

G-CSF therapy in acute liver failure and alcoholic hepatitis
Experimental group
Description:
G-CSF therapy given in cases with acute liver failure and alcoholic hepatitis
Treatment:
Drug: Granulocyte colony stimulating factor

Trial contacts and locations

1

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Central trial contact

Arun Sharma, DM; Virendra Singh

Data sourced from clinicaltrials.gov

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