drugset / Trial / NCT02442180

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

NCT02442180

Phase 3 Terminated 64 enrolled Chuncheon Sacred Heart Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-07
Primary completion
2022-07
Completion
2022-07

Drugs

EvaluationDrugModalityDoseRoute
Subject filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous
Background Methylprednisolone Other / unclassified 32 mg Intravenous
Background Prednisolone Other / unclassified 40 mg Oral

Indications