drugset / Trial / NCT04066179

Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.

NCT04066179

RandomizedParallel-groupOpen-labelTreatment

Summary

The patients of Severe Alcoholic Hepatitis (SAH) will be included in study based on inclusion and exclusion criteria. The patients will be then randomized in 3 groups for therapy. They will receive either steroid or Granulocyte-Colony Stimulating Factor (GCSF) or both. They will be followed for atleast 90 days for improvements in symptoms and various predefined parameters. Primary outcome will be improvement in survival at 90 Days. Patients will be monitored at every follow up for disease progression and complications of therapy. The study results will be analyzed for differences in survival rate and complications in different groups to propose new therapeutic guideline in SAH patients.

Timeline

Start
2019-09-07
Primary completion
2021-02-27
Completion
2021-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Prednisolone Other / unclassified 40 mg

Indications