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

• Status: Unknown status
• Trial end date: 2021-02-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Lenograstim; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sargramostim

Criteria

Inclusion Criteria:

• Severe alcoholic hepatitis patients [Maddrey's score > 32] aged between 18 to 65 years.

Exclusion Criteria:

• Presence of active infections

• Acute Gastrointestinal bleed

• Hepatorenal syndrome

• Patient unwilling

• Discriminant Function >90

• Autoimmune hepatitis

• Hepatitis B, Hepatitis C, Human immunodeficiency Virus cases

• Pregnancy

• Hemophagocytic lymphohistiocytosis (HLH)

• Hb<8 and baseline White Blood Cell>25000