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