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

Phase 4

• Conditions: Liver Failure; Hepatitis B; Alcoholic Liver Disease
• Interventions: Drug: Granulocyte colony-stimulating factor; Drug: standard treatment

• Registration Number: NCT02331745
• Lead Sponsor: Beijing 302 Hospital

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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-12-24
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Primary Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-04
• Last Update Posted: 2016-08-05
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Granulocyte colony-stimulating factor	Granulocyte 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). 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
Granulocyte colony-stimulating factor	standard treatment	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	standard treatment	Standard treatment alone

Primary Outcome Measures

Name	Time	Method
Survival rates	12 weeks

Secondary Outcome Measures

Name	Time	Method
(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
incidence of complications;including infection, HRS	at 4 weeks; and at 12 weeks
Total Bilirubin,TbiL	at 4 weeks; and at 12 weeks

Trial Locations

Locations (1)

Beijing; 302 Military Hospital; 🇨🇳 Beijing, China