Alcoholic Liver Disease, Hepatitis B, Liver Failure
Conditions
Brief summary
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
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
Interventions
DRUGGranulocyte colony-stimulating factor
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).
DRUGstandard treatment
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
Sponsors
Beijing 302 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. age from 17ys to 70ys; 2. fale or femal; 3. 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
1. super-infection or co-infection with hepatitis A, C, D, E,Epstein-Barr virus, cytomegalovirus, or human immunodeficiency virus; 2. a previous course immuno-modulator or cytotoxic/immunosuppressive therapy for chronic hepatitis within the prior 12 mo; 3. hepato-cellular carcinoma diagnosed by computed tomography or magnetic resonance imaging; 4. co-existence of any other serious medical illnesses or other liver diseases such as autoimmune hepatitis, drug-induced liver injury or Wilson's disease; 5. any concurrent evidence of sepsis; 6. malignant jaundice induced by obstructive jaundice and hemolytic jaundice; 7. prolonged prothrombin time due to blood system disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rates | 12 weeks |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactJinhua Hu, Dr. and PhD
Backup ContactJinbiao Ding, Dr.
Outcome results
None listed