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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02331745
• Other study ID #: Z131107002213157
• Status: Recruiting
• Phase: Phase 4
• First received: December 24, 2014
• Last updated: August 4, 2016
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: August 2016
• Source: Beijing 302 Hospital
• Contact: Jinhua Hu, Dr. and PhD
• Phone: 861066933405
• Email: hjh[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: October 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

Inclusion Criteria:

1. age from 17ys to 70ys;

2. fale or femal;

3. ACLF, as de?ned 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

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

Related Conditions & MeSH terms

• Alcoholic Liver Disease
• Hepatitis B
• Liver Diseases
• Liver Diseases, Alcoholic
• Liver Failure

Intervention

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).
• 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

Locations

Country	Name	City	State
China	Beijing; 302 Military Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rates		12 weeks	Yes
Secondary	(Model of End Liver Disease,MELD) score		at 4 weeks; and at 12 weeks	Yes
Secondary	(Sepsis-related Organ Failure Assessment,SOFA) score		at 4 weeks; and at 12 weeks	Yes
Secondary	Total Bilirubin,TbiL		at 4 weeks; and at 12 weeks	Yes
Secondary	incidence of complications;including infection, HRS		at 4 weeks; and at 12 weeks	Yes