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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Granulocyte colony-stimulating factor | Experimental | 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 |
|
| standard treatment | Active Comparator | Standard treatment alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granulocyte colony-stimulating factor | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rates | 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinhua Hu, Dr. and PhD | Contact | 861066933405 | hjh@medmail.com.cn | |
| Jinbiao Ding, Dr. | Contact | 861066933462 | dingjb163@163.com |
| Name | Affiliation | Role |
|---|---|---|
| jinhua hu, Dr. and PhD | Beijing; 302 Military Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing; 302 Military Hospital | Recruiting | Beijing | 100039 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35651610 | Derived | Tong J, Wang H, Xu X, Wan Z, Fang H, Chen J, Mu X, Liu Z, Chen J, Su H, Liu X, Li C, Huang X, Hu J. Granulocyte Colony-Stimulating Factor Accelerates the Recovery of Hepatitis B Virus-Related Acute-on-Chronic Liver Failure by Promoting M2-Like Transition of Monocytes. Front Immunol. 2022 May 16;13:885829. doi: 10.3389/fimmu.2022.885829. eCollection 2022. |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D006509 | Hepatitis B |
| D008108 | Liver Diseases, Alcoholic |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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|
| standard treatment | Drug | 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 |
|
|
| at 4 weeks; and at 12 weeks |
| incidence of complications;including infection, HRS | at 4 weeks; and at 12 weeks |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |