Efficacy and Safety of G-CSF in Patients With Severe Alcoholic Hepatitis With Null or Partial Response to Steroid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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Severe alcoholic hepatitis is defined as alcoholic hepatitis patients having discriminant function (DF) score over 32 or accompanying hepatic encephalopathy. These patients have shown poor prognosis of 28 day mortality as 30 to 50% without treatment. Steroid (prednisolone 40mg/day for 28 days) is the treatment of choice in patients with severe alcoholic hepatitis. Alcoholic hepatitis with modified DF score greater than or equal to 32 or model for end-stage liver disease (MELD) score over 21 or with hepatic encephalopathy are indications. 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. Even in the responders of steroid treatment, the mortality is still 20% (from 40% without treatment to 20% with steroid treatment). There is a need for development of new treatment for this catastrophic disease. 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.

Conditions

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Alcoholic Hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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G-CSF + steroid in partial responder

Patients who are randomized to prednisolone plus G-CSF treatment group in patients with partial responder to prednisolone therapy.

Group Type EXPERIMENTAL

G-CSF (Filgrastim injection)

Intervention Type DRUG

G-CSF (Filgrastim injection) 5ug/kg subcutaneous injection daily for 5 days and every 3 days (total 12 doses)

steroid

Intervention Type DRUG

oral prednisolone 40mg qd or iv methylprednisolone 32 mg if oral medication is not tolerable

Placebo + steroid in partial responder

Patients who are randomized to prednisolone plus placebo treatment group in patients with partial responder to prednisolone therapy.

Group Type PLACEBO_COMPARATOR

steroid

Intervention Type DRUG

oral prednisolone 40mg qd or iv methylprednisolone 32 mg if oral medication is not tolerable

placebo

Intervention Type DRUG

equivalent to G-CSF doses

G-CSF in null responder to steroid

Patients who are randomized to G-CSF treatment group in patients with null responder to prednisolone therapy.

Group Type EXPERIMENTAL

G-CSF (Filgrastim injection)

Intervention Type DRUG

G-CSF (Filgrastim injection) 5ug/kg subcutaneous injection daily for 5 days and every 3 days (total 12 doses)

Placebo in null responder to steroid

Patients who are randomized to placebo treatment group in patients with null responder to prednisolone therapy.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

equivalent to G-CSF doses

Interventions

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G-CSF (Filgrastim injection)

G-CSF (Filgrastim injection) 5ug/kg subcutaneous injection daily for 5 days and every 3 days (total 12 doses)

Intervention Type DRUG

steroid

oral prednisolone 40mg qd or iv methylprednisolone 32 mg if oral medication is not tolerable

Intervention Type DRUG

placebo

equivalent to G-CSF doses

Intervention Type DRUG

Other Intervention Names

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Filgrastim (brand name), Recombinant Filgrastim prednisolone or methylprednisolone normal saline

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No