Granulocyte Colony Stimulating Factor(G-CSF) Therapy for Patients With ACLF

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Govind Ballabh Pant Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT01036932
First received: December 17, 2009
Last updated: December 18, 2009
Last verified: December 2009

December 17, 2009
December 18, 2009
December 2008
August 2010   (final data collection date for primary outcome measure)
mobilization of CD34 cells in the peripheral blood [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01036932 on ClinicalTrials.gov Archive Site
  • clinical/ biochemical improvement in liver function profile [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • frequency of multi-organ failure [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Granulocyte Colony Stimulating Factor(G-CSF) Therapy for Patients With ACLF
To Study the Safety and Efficacy of G-CSF Therapy on the CD 34 Cell Mobilization and Outcome of Patients With ACLF

The purpose of the study is to determine whether Granulocyte Colony Stimulating factor(G-CSF) therapy is effective in the treatment of patients with Acute on chronic liver failure(ACLF). The investigators hypothesize that ACLF is a disease where severe hepatic impairment is accompanied by impaired hepatic regeneration. BMC mobilization using G-CSF therapy, or G-CSF therapy per se would increase the regenerative capacity of the liver and shall lead to clinical, biochemical and histological improvements in patients with ACLF.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Acute on Chronic Liver Failure
  • Drug: Granulocyte Colony Stimulating Factor
    Dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy.
  • Drug: Normal Saline
    dose of 1ml s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy.
  • Active Comparator: G-CSF group
    Patients with Acute on chronic liver failure after baseline investigations for the etiology of the acute event and the underlying chronic disease were given Granulocyte Colony Stimulating Factor therapy for a total duration of one month.
    Intervention: Drug: Granulocyte Colony Stimulating Factor
  • Placebo Comparator: Placebo
    After baseline characterization and work up for underlying acute and chronic liver disease, patients were given placebo along with the standard therapy
    Intervention: Drug: Normal Saline
Garg V, Garg H, Khan A, Trehanpati N, Kumar A, Sharma BC, Sakhuja P, Sarin SK. Granulocyte colony-stimulating factor mobilizes CD34(+) cells and improves survival of patients with acute-on-chronic liver failure. Gastroenterology. 2012 Mar;142(3):505-512.e1. Epub 2011 Nov 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease.(APASL criteria)

Exclusion Criteria:

  • HCC or portal vein thrombosis. Refusal to participate in the study. Sepsis ( Any culture positive: blood, urine, focus of infection on Xray chest, any other obvious source of infection: UTI, SBP) Multi organ failure. Grade 3 or 4 hepatic encephalopathy.
Both
12 Years to 75 Years
No
India
 
NCT01036932
IEC MAMC 179
Yes
Dr S.K.Sarin, Head, Gastroenterology
Govind Ballabh Pant Hospital
Not Provided
Principal Investigator: Shiv K Sarin, MD, DM G B Pant Hospital, New Delhi, India
Govind Ballabh Pant Hospital
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP