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

• Status: Unknown status
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing 302 Hospital
• Treatments: Lenograstim; Polyene phosphatidylcholine; Sargramostim

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.