Clinical trial NCT02331745: RCT Study on Granulocyte Colony-stimulating Factor(G-CSF) Treatment of Hepatic Failure
Official title: Granulocyte Colony-stimulating Factor(G-CSF) in the Treatment of Hepatic Failure: a Prospective Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Failure
Hepatitis B
Alcoholic Liver Disease
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 140
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Survival rates
timeFrame: 12 weeks
Secondary outcomes:
measure: (Model of End Liver Disease,MELD) score
timeFrame: at 4 weeks; and at 12 weeks
measure: (Sepsis-related Organ Failure Assessment,SOFA) score
timeFrame: at 4 weeks; and at 12 weeks
measure: Total Bilirubin,TbiL
timeFrame: at 4 weeks; and at 12 weeks
measure: incidence of complications;including infection, HRS
timeFrame: at 4 weeks; and at 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing; 302 Military Hospital
Study officials:
affiliation: Beijing; 302 Military Hospital
name: jinhua hu, Dr. and PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.