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

NCT02442180 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-08-08

No results posted yet for this study

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.

Conditions

  • Alcoholic Hepatitis

Interventions

DRUG

G-CSF (Filgrastim injection)

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

DRUG

steroid

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

DRUG

placebo

equivalent to G-CSF doses

Sponsors & Collaborators

  • Chuncheon Sacred Heart Hospital

    lead OTHER

Principal Investigators

  • Dong Joon Kim, M.D., Ph.D. · Hallym Universitiy College of Medicine, Chuncheon Sacred Heart hospital, Chuncheon, South Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02442180 on ClinicalTrials.gov