Granulocyte Colony Stimulating Factor (G-CSF) in Acute Liver Failure and Alcoholic Hepatitis
G-CSF
G-CSF in Acute Liver Failure and Alcoholic Hepatitis - A Pilot Study
1 other identifier
interventional
60
1 country
1
Brief Summary
Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 15, 2011
CompletedFirst Posted
Study publicly available on registry
April 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedApril 26, 2011
January 1, 2011
1 year
April 15, 2011
April 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
• Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization
1 year
Secondary Outcomes (1)
clinical and biochemical improvement in liver functions
1 year
Study Arms (1)
G-CSF therapy in acute liver failure and alcoholic hepatitis
EXPERIMENTALG-CSF therapy given in cases with acute liver failure and alcoholic hepatitis
Interventions
300 I.U twice daily for 5 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Postgraduate Institute of Medical Education & Research Chandigarh India
Chandigarh, Chandigarh, 1600012, India
Related 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.
PMID: 18537187BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
virendra singh
Postgraduate Institute of Medical Education and Research Chandigarh India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 15, 2011
First Posted
April 26, 2011
Study Start
June 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
April 26, 2011
Record last verified: 2011-01