ClinicalTrials.gg
Sign In
Status unknownNCT01341951G-CSFUpdated Apr 26, 2011

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

An interventional study of Granulocyte colony stimulating factor in Liver Failure, Acute, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Status unknown at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-26.

Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis

Read the 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.

02

Conditions studied

  • Liver Failure, Acute

Browse trials for

Keywords

  • liver failure, Acute
03

In context

Liver Failure, Acute

100 studies on the registry are indexed under Liver Failure, Acute; 19 are open to participants now.

This study's planned enrollment of 60 is above the median of 45 across 47 interventional studies indexed under Liver Failure, Acute.

Browse Liver Failure, Acute studies →

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 296 studies on the registry; 44 are open to participants now.

Browse Post Graduate Institute of Medical Education and Research, Chandigarh studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

Interventions

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. clinical and biochemical improvement in liver functions

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Postgraduate Institute of Medical Education & Research Chandigarh India
    Chandigarh, Chandigarh 1600012, India
    Recruiting
08

References and documents

Publications

  • 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. PubMed 18537187 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2010, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2011
First posted
Apr 26, 2011
Start
Jun 2010
Primary completionEst.
Jun 2011
CompletionEst.
Jun 2011
Last update
Apr 26, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01341951
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
First posted
Apr 26, 2011
Start date
Jun 2010
Primary completion
Jun 2011 (estimated)
Completion
Jun 2011 (estimated)
Last update
Apr 26, 2011

Study contacts

Arun Sharma, DM
Contact
drarunvashisht@yahoo.co.in
08872721666
Virendra Singh
Contact
virendrasingh100@hotmail.com
09914209338
virendra singh
principal investigator · Postgraduate Institute of Medical Education and Research Chandigarh India

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Granulocyte Colony-Stimulating Factor

Other studies in this condition

Liver Failure, Acute →

Other studies from this sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh →

Start the discussion