RCT Study on Granulocyte Colony-stimulating Factor(G-CSF) Treatment of Hepatic Failure
Granulocyte Colony-stimulating Factor(G-CSF) in the Treatment of Hepatic Failure: a Prospective Randomized Controlled Clinical Study
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 24, 2014
CompletedFirst Posted
Study publicly available on registry
January 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedAugust 5, 2016
August 1, 2016
2.5 years
December 24, 2014
August 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Survival rates
12 weeks
Secondary Outcomes (4)
(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
Study Arms (2)
Granulocyte colony-stimulating factor
EXPERIMENTALGranulocyte 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
ACTIVE COMPARATORStandard treatment alone
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing; 302 Military Hospital
Beijing, 100039, China
Related Publications (1)
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.
PMID: 35651610DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jinhua hu, Dr. and PhD
Beijing; 302 Military Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. & Chief Physician
Study Record Dates
First Submitted
December 24, 2014
First Posted
January 6, 2015
Study Start
October 1, 2013
Primary Completion
April 1, 2016
Study Completion
October 1, 2016
Last Updated
August 5, 2016
Record last verified: 2016-08