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

Sponsor

Beijing 302 Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02331745

Collaborator

(none)

140

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Failure Hepatitis B Alcoholic Liver Disease	Drug: Granulocyte colony-stimulating factor Drug: standard treatment	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Apr 1, 2016

Anticipated Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: 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). Other Names: G-CSF Drug: standard 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 Other Names: SDT
Active Comparator: standard treatment Standard treatment alone	Drug: standard 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 Other Names: SDT

Arm

Intervention/Treatment

Experimental: 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

Drug: 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).

Other Names:

G-CSF

Drug: standard 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

Other Names:

SDT

Active Comparator: standard treatment

Standard treatment alone

Drug: standard treatment

Other Names:

SDT

Outcome Measures

Primary Outcome Measures

Survival rates [12 weeks]

Secondary Outcome Measures

(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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age from 17ys to 70ys;
fale or femal;
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:

super-infection or co-infection with hepatitis A, C, D, E,Epstein-Barr virus, cytomegalovirus, or human immunodeficiency virus;
a previous course immuno-modulator or cytotoxic/immunosuppressive therapy for chronic hepatitis within the prior 12 mo;
hepato-cellular carcinoma diagnosed by computed tomography or magnetic resonance imaging;
co-existence of any other serious medical illnesses or other liver diseases such as autoimmune hepatitis, drug-induced liver injury or Wilson's disease;
any concurrent evidence of sepsis;
malignant jaundice induced by obstructive jaundice and hemolytic jaundice;
prolonged prothrombin time due to blood system disease.