Cho 2018.

Study name	Efficacy of granulocyte colony stimulating factor in patients with severe alcoholic hepatitis with partial or null response to steroid (GRACIAH trial): study protocol for a randomised controlled trial
Methods	Prospective, double‐blind, multicentre (15 centres), randomised placebo‐controlled trial, with 2 parallel subgroups
Participants	Patients with severe alcoholic hepatitis, with high mortality, despite corticosteroid treatment. Inclusion criteria Age > 20 years and < 80 years History of clinically significant amount of alcohol intake (≥ 50 g daily for men, and ≥ 40 g daily for women over the last 2 months) MDF during the screening period = [4.6 × (patient’s prothrombin time, sec − control prothrombin time, sec)] + serum bilirubin level (mg/dL) ≥ 32 New occurrence of jaundice within the last 3 months when a liver biopsy could not be performed, (total serum bilirubin level > 5 mg/dL), or pathological transjugular liver tissue biopsy results consistent with alcoholic hepatitis (hepatocellular ballooning and polymorphonuclear leukocytic infiltration) After satisfying criteria 1 to 4, Lille score > 0.16 on day 7 after daily administration of 40 mg prednisolone (or intravenous methylprednisolone at the equivalent efficacy dose in the case of oral intolerability)
Interventions	Experimental G‐CSF (Leucostim® Injection, Dong‐A ST Co., Ltd., Seoul, Korea, nomenclature of component filgrastim) subcutaneously administered 12 times (daily for 5 days, followed by every 3 days for 7 times) at the dose of 200 to 300 μg according to body weight Control Normal saline (JW Pharmaceutical, Seoul, Korea) used as a placebo at a maximal volume of 1.2 ml.
Outcomes	The primary aim was to evaluate whether G‐CSF treatment prolongs 6‐month overall survival (OS) of participants with a partial response (PR) to steroids and 2‐month OS of participants with a null response (NR) to steroids. Partial responders (0.16 < Lille score < 0.56) or null responders (Lille score ≥ 0.56) are identified based on the Lille score after 1 week of corticosteroid treatment (40 mg daily prednisolone dose). The secondary aims were to identify the risk factors in relation to mortality and the predictive factors associated with responses to standard corticosteroid treatment or rescue G‐CSF therapy.
Starting date	Recruitment started on 13 May 2015. The estimated primary completion date was April 2022 (estimated study completion: December 2022). The enrolment was terminated (failure to recruit eligible participants) in July 2022, but results are still not available.
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G‐CSF: granulocyte colony‐stimulating factor; MDF: Maddrey's discriminant function score