Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Granulocyte-colony Stimulating Factor in Patients With Severe Alcoholic Hepatitis With Null or Partial Response to Steroid: A Randomized, Double-blind, Placebo-controlled, Nationwide Multi-center Study
Brief Summary: Steroid is the treatment of choice in patients with severe alcoholic hepatitis. However, null- or partial responder of steroid treatment is recommended to consider liver transplantation. The yearly demand for liver transplants far exceeds the supply of available organs and alcoholic liver disease has been a controversial indication for transplantation. Granulocyte-Colony Stimulating Factor (G-CSF) has been reported to have effect of proliferation of hepatic progenitors in alcoholic steatohepatitis. The aim of this study is to investigate the efficacy of G-CSF in patients with severe alcoholic hepatitis with null or partial response to steroid.


Options:
A: Inclusion Criteria: Patients with

* Clinical significant alcohol intake history (men over 50g within 3 months, women over 40g within 3 months)
* modified DF score greater than or equal to 32
* Transjugular liver biopsy shows typical feature of alcoholic hepatitis or meet the clinical diagnosis (total serum bilirubin level over 5 mg/dL, aspartate aminotransferase/alanine aminotransferase ratio \>2, aspartate aminotransferase \< 300 IU/L)
* Included patients should meet the all above criteria and Lille score \> 0.16 at the day 7 of prednisolone 40mg (or 32 mg of methylprednisolone) daily treatment.

Exclusion Criteria: Patients with

* hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV), or anti-human immunodeficiency virus (HIV) (+)
* Malignancy including hepatocellular carcinoma
* Portal vein thrombosis, hemochromatosis, autoimmune hepatitis, Wilson's disease, alpha-1-antitrypsin deficiency
* Pregnancy, breast feeding, or who refuses contraception, or who cannot do contraception
* History of adverse event including allergic response, hypersensitivity to G-CSF
* Hypovolemic shock due to gastrointestinal hemorrhage or who need packed red blood cell (RBC) transfusion more than 3 units or increased modified discriminant factor (DF) score greater or equal to 32 from below 32 due to gastrointestinal hemorrhage
* Sepsis or uncontrolled acute infection
* Hepatic encephalopathy grade 3-4
* History of steroid or pentoxifylline treatment within 3 months
* Myeloblast on peripheral blood smear test
* Critical comorbidities (type I hepatorenal syndrome, serum creatinine \>2.5mg/dL, heart failure, pulmonary disease, psychiatric disease, acute pancreatitis etc.)
* Who refuses to participate in clinical trial
B: 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.
C: Inclusion Criteria:

* Subjects aged 18-65 years
* All patients who are known to have cirrhosis of liver with portal hypertension and are compensated on presentation with no features of ascites/ jaundice/ bleed/ HE/ HRS.
* Only patients with alcoholic cirrhosis and cryptogenic cirrhosis (etiology work up negative) will be enrolled in the study.

Exclusion Criteria:

* Sepsis ( Any culture positive: blood, urine, any other obvious source of infection: UTI, LRTI)
* Variceal bleed in the past 3 months
* Autoimmune disorders
* HCC (Hepatocellular Carcinoma)
* Multi organ failure
* Any features of decompensation in form of ascites/Jaundice/ HE (grade 3 or 4) / HRS
* HIV seropositivity
* Essential hypertension
* Pregnancy
* Refusal to participate in the study
D: Inclusion Criteria:

* A clinical diagnosis of alcoholic hepatitis with Maddrey's discriminant function score ≥32. Age 18 years or older.

Exclusion Criteria:

* Renal failure (creatinine \>2.0 mg/dl)
* Bilirubin \<5 mg/dL
* uncontrolled recent upper gastrointestinal bleeding
* Known HIV infection
* Uncontrolled infection, or pregnant.

Answer: A