Efficacy and Safety of G-CSF in Patients With Severe Alcoholic Hepatitis With Null or Partial Response to Steroid (GraCiAH)
Alcoholic Hepatitis
About this trial
This is an interventional treatment trial for Alcoholic Hepatitis
Eligibility Criteria
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
Sites / Locations
- Chuncheon Sacred Heart hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
G-CSF + steroid in partial responder
Placebo + steroid in partial responder
G-CSF in null responder to steroid
Placebo in null responder to steroid
Patients who are randomized to prednisolone plus G-CSF treatment group in patients with partial responder to prednisolone therapy.
Patients who are randomized to prednisolone plus placebo treatment group in patients with partial responder to prednisolone therapy.
Patients who are randomized to G-CSF treatment group in patients with null responder to prednisolone therapy.
Patients who are randomized to placebo treatment group in patients with null responder to prednisolone therapy.