Alcoholic Hepatitis Clinical Trial
Official title:
Granulocyte Colony Stimulating Factor in Alcoholic Hepatitis
Alcoholic hepatitis is related to very high mortality rate. About 40% of the patients are
died within first 6 months after the detection of the clinical syndrome. Therefore, it is
very essential for proper diagnosis and early treatment. In response to acute or chronic
liver damage, bone marrow derived stem cells can spontaneously populate liver and
differentiate into hepatic cells. Animal and human studies suggested that injured hepatocyte
may be replaced by pluripotent bone marrow cells. However, this hepatocyte repopulation is
highly dependent on varieties of liver injury and therapeutic conditions. The studies has
suggested Granulocyte-colony stimulating factors (G-CSF) can regenerate hepatocyte by fusing
with hematopoietic cells, thereby enhancing the liver histology and survival rate.
G-CSF is a cytokine capable to regulate a number of functions in neutrophils. In three recent
studies mobilization of bone marrow stem cells induced by G-CSF was observed in patients with
alcoholic hepatitis. In two of this studies there was a survival benefit with the use of
G-CSF.
Therefore we plan to study the safety and efficacy of G-CSF in the patients with alcoholic
hepatitis.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 18, 2020 |
Est. primary completion date | November 18, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Alcoholic hepatitis patients: 1. More than 10 years of heavy alcohol consumption (mean intake ˜ 100 g/day). 2. Elevated aspartate aminotransferase level (but <500 IU per millilitre) and Ratio ofAST/ALT=2 times 3. Elevated serum total bilirubin level = 5 mgdL (86 µmol/L) 4. Elevated INR(=1.5) and 5. Neutrophilia. Patient with Maddrey's DF of = 32 will be included in the study, with or without biopsy. Exclusion Criteria: - 1. Age < 18 and > 75 years 2. Hepatocellular carcinoma or portal vein thrombosis 3. Refusal to participate in the study 4. Serum creatinine>1.0 mg% 5. Hepatic encephalopathy- grade 3 or 4 6. Upper gastrointestinal bleed in last ten days 7. Uncontrolled bacterial infection 8. Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus seropositivity, Autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency 9. Pregnancy 10. Glucocorticoid treatment 11. Significant co-morbidity 12. Previous known hypersensitivity to G-CSF |
Country | Name | City | State |
---|---|---|---|
India | Post Graduate Institute of Medical Education and Research | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival at 3 months | 90 DAYS | ||
Secondary | Mobilisation of CD34 positive cells in peripheral blood. | 6 DAYS | ||
Secondary | Improvement in MELD score | 90 DAYS | ||
Secondary | Improvement in Maddrey's Discriminant Function. | 90 Days | ||
Secondary | Improvement in Child Turcotte Pugh score. | 90 Days | ||
Secondary | Number of participants with treatment-related adverse events in the different groups. | 90 Days |
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