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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02331745
Recruitment Status : Unknown
Verified August 2016 by Jinhua Hu, Beijing 302 Hospital.
Recruitment status was:  Recruiting
First Posted : January 6, 2015
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Jinhua Hu, Beijing 302 Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2013
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: SDT


Outcome Measures
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Primary Outcome Measures :
  1. Survival rates [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. (Model of End Liver Disease,MELD) score [ Time Frame: at 4 weeks; and at 12 weeks ]
  2. (Sepsis-related Organ Failure Assessment,SOFA) score [ Time Frame: at 4 weeks; and at 12 weeks ]
  3. Total Bilirubin,TbiL [ Time Frame: at 4 weeks; and at 12 weeks ]
  4. incidence of complications;including infection, HRS [ Time Frame: at 4 weeks; and at 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331745


Contacts
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Contact: Jinhua Hu, Dr. and PhD 861066933405 hjh@medmail.com.cn
Contact: Jinbiao Ding, Dr. 861066933462 dingjb163@163.com

Locations
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China
Beijing; 302 Military Hospital Recruiting
Beijing, China, 100039
Contact: Jinbiao Ding, Dr.    86106693462    dingjb163@163.com   
Sponsors and Collaborators
Beijing 302 Hospital
Investigators
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Principal Investigator: jinhua hu, Dr. and PhD Beijing; 302 Military Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jinhua Hu, Prof. & Chief Physician, Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT02331745    
Other Study ID Numbers: Z131107002213157
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Hepatitis B
Liver Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases, Alcoholic
Hepatitis
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Hepadnaviridae Infections
 DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs