Liver Failure, Acute Clinical Trial
— G-CSFOfficial title:
G-CSF in Acute Liver Failure and Alcoholic Hepatitis - A Pilot Study
Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Postgraduate Institute of Medical Education & Research Chandigarh India | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | • Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization | 1 year | No | |
Secondary | clinical and biochemical improvement in liver functions | 1 year | Yes |
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