drugset / Trial / NCT02442180
Efficacy and Safety of G-CSF in Patients With Severe Alcoholic Hepatitis With Null or Partial Response to Steroid
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Background | Methylprednisolone | Other / unclassified | 32 mg | Intravenous |
| Background | Prednisolone | Other / unclassified | 40 mg | Oral |