RCT Study on Granulocyte Colony-stimulating Factor(G-CSF) Treatment of Hepatic Failure

Study Overview
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Brief Summary
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This study evaluates the Granulocyte colony-stimulating factor (G-CSF) in the treatment of Acute on Chronic Liver Failure in adult. Half participants will receive G-CSF and standard treatment in combination, while half participants will receive standard treatment.

Detailed Description
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Granulocyte colony-stimulating factor (G-CSF) can be used to mobilize stem cells to the periphery and the liver tissue in patients with advanced liver disease, and could promote hepatic regeneration. Moreover, G-CSF was reported to protect patients from sepsis by restoring the function of both neutrophils and monocytes. Therefore, G-CSF therapy may be beneficial for liver regeneration in patients with ACLF induced by different causes. standard therapy for the treatment of ACLF includes reduced glutathione, glycyrrhizin, ademetionine,polyene phosphatidylcholine, alprostadil, and human serum albumin) on the day of admission. HBV associated ACLF patients receive entecavir at the same time

Official Title
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Granulocyte Colony-stimulating Factor(G-CSF) in the Treatment of Hepatic Failure: a Prospective Randomized Controlled Clinical Study

Conditions
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Liver Failure, Hepatitis B, Alcoholic Liver Disease

Intervention / Treatment
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* Drug: Granulocyte colony-stimulating factor
* Drug: standard treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age from 17ys to 70ys; fale or femal; ACLF, as deﬁned by the Asian Pacific Association for the Study of the Liver Working Party, is an acute hepatic insult manifested as jaundice (serum bilirubin ≥ 5 mg/dL) and coagulopathy[international normalized ratio (INR) ≥ 1.5 or prothrombin activity< 40%], with complications of ascites and/or encephalopathy within 4 wk in patients previously diagnosed or undiagnosed with chronic HBV associated liver disease and alcoholic liver Exclusion Criteria: super-infection or co-infection with hepatitis A, C, D, E,Epstein-Barr virus, cytomegalovirus, or human immunodeficiency virus; a previous course immuno-modulator or cytotoxic/immunosuppressive therapy for chronic hepatitis within the prior 12 mo; hepato-cellular carcinoma diagnosed by computed tomography or magnetic resonance imaging; co-existence of any other serious medical illnesses or other liver diseases such as autoimmune hepatitis, drug-induced liver injury or Wilson's disease; any concurrent evidence of sepsis; malignant jaundice induced by obstructive jaundice and hemolytic jaundice; prolonged prothrombin time due to blood system disease.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Granulocyte colony-stimulating factor<br>Granulocyte colony-stimulating factor(G-CSF) was given 5 ug/kg subcutaneously qd for 6 doses,then qod for other 6 doses(total 12 doses). Standard treatment includes reduced glutathione, glycyrrhizin, ademetionine,polyene phosphatidylcholine, alprostadil, and human serum albumin) on the day of admission. HBV associated ACLF patients receive entecavir at the same time | Drug: Granulocyte colony-stimulating factor<br>* Granulocyte colony-stimulating factor(G-CSF) was given 5 ug/kg subcutaneously qd for 6 doses,then qod for other 6 doses(total 12 doses).<br>* Other names: G-CSF;Drug: standard treatment<br>* Standard treatment includes reduced glutathione, glycyrrhizin, ademetionine,polyene phosphatidylcholine, alprostadil, and human serum albumin) on the day of admission. HBV associated ACLF patients receive entecavir at the same time<br>* Other names: SDT;|
| Active Comparator: standard treatment<br>Standard treatment alone | Drug: standard treatment<br>* Standard treatment includes reduced glutathione, glycyrrhizin, ademetionine,polyene phosphatidylcholine, alprostadil, and human serum albumin) on the day of admission. HBV associated ACLF patients receive entecavir at the same time<br>* Other names: SDT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rates |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Model of End Liver Disease,MELD) score |  | at 4 weeks; and at 12 weeks | 
| (Sepsis-related Organ Failure Assessment,SOFA) score |  | at 4 weeks; and at 12 weeks | 
| Total Bilirubin,TbiL |  | at 4 weeks; and at 12 weeks | 
| incidence of complications;including infection, HRS |  | at 4 weeks; and at 12 weeks |