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

Information source: Beijing 302 Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Failure; Hepatitis B; Alcoholic Liver Disease

Intervention: Granulocyte colony-stimulating factor (Drug); standard treatment (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Beijing 302 Hospital

Official(s) and/or principal investigator(s):
jinhua hu, Dr. and PhD, Principal Investigator, Affiliation: Beijing; 302 Military Hospital

Overall contact:
Jinhua Hu, Dr. and PhD, Phone: 861066933405, Email: hjh@medmail.com.cn


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Survival rates

Secondary outcome:

(Model of End Liver Disease,MELD) score

(Sepsis-related Organ Failure Assessment,SOFA) score

Total Bilirubin,TbiL

incidence of complications;including infection, HRS

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


Minimum age: 17 Years. Maximum age: 70 Years. Gender(s): Both.


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.

Locations and Contacts

Jinhua Hu, Dr. and PhD, Phone: 861066933405, Email: hjh@medmail.com.cn

Beijing; 302 Military Hospital, Beijing 100039, China; Recruiting
Jinbiao Ding, Dr., Phone: 86106693462, Email: dingjb163@163.com
Additional Information

Starting date: October 2013
Last updated: January 5, 2015

Page last updated: August 23, 2015

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