search
Back to results

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

Primary Purpose

Liver Failure, Hepatitis B, Alcoholic Liver Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Granulocyte colony-stimulating factor
standard treatment
Sponsored by
Beijing 302 Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Failure

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing; 302 Military HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Granulocyte colony-stimulating factor

standard treatment

Arm Description

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 alone

Outcomes

Primary Outcome Measures

Survival rates

Secondary Outcome Measures

(Model of End Liver Disease,MELD) score
(Sepsis-related Organ Failure Assessment,SOFA) score
Total Bilirubin,TbiL
incidence of complications;including infection, HRS

Full Information

First Posted
December 24, 2014
Last Updated
August 4, 2016
Sponsor
Beijing 302 Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02331745
Brief Title
RCT Study on Granulocyte Colony-stimulating Factor(G-CSF) Treatment of Hepatic Failure
Official Title
Granulocyte Colony-stimulating Factor(G-CSF) in the Treatment of Hepatic Failure: a Prospective Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing 302 Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure, Hepatitis B, Alcoholic Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Granulocyte colony-stimulating factor
Arm Type
Experimental
Arm Description
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
Arm Title
standard treatment
Arm Type
Active Comparator
Arm Description
Standard treatment alone
Intervention Type
Drug
Intervention Name(s)
Granulocyte colony-stimulating factor
Other Intervention Name(s)
G-CSF
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
standard treatment
Other Intervention Name(s)
SDT
Intervention Description
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
Primary Outcome Measure Information:
Title
Survival rates
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
(Model of End Liver Disease,MELD) score
Time Frame
at 4 weeks; and at 12 weeks
Title
(Sepsis-related Organ Failure Assessment,SOFA) score
Time Frame
at 4 weeks; and at 12 weeks
Title
Total Bilirubin,TbiL
Time Frame
at 4 weeks; and at 12 weeks
Title
incidence of complications;including infection, HRS
Time Frame
at 4 weeks; and at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinhua Hu, Dr. and PhD
Phone
861066933405
Email
hjh@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jinbiao Ding, Dr.
Phone
861066933462
Email
dingjb163@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jinhua hu, Dr. and PhD
Organizational Affiliation
Beijing; 302 Military Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing; 302 Military Hospital
City
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinbiao Ding, Dr.
Phone
86106693462
Email
dingjb163@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
35651610
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs