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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01341951

Acronym

G-CSF

Enrollment

Registered

2011-04-26

Start date

2010-06-30

Completion date

2011-06-30

Last updated

2011-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Failure, Acute

Keywords

liver failure, Acute

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.

Interventions

DRUGGranulocyte colony stimulating factor

300 I.U twice daily for 5 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
clinical and biochemical improvement in liver functions	1 year

Countries

India

Contacts

Primary ContactArun Sharma, DM

drarunvashisht@yahoo.co.in08872721666

Backup ContactVirendra Singh

virendrasingh100@hotmail.com09914209338

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026