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

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Alcoholic Hepatitis

Treatments: Drug: Gcsf; Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT04066179

ILBS-AH-03

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 3 patient groups

Prednisolone+G-CSF

Experimental group

Description:

Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days

Treatment:

Drug: Gcsf

Drug: Prednisolone

Prednisolone

Active Comparator group

Description:

Prednisolone 40 mg/day for 7 days

Treatment:

Drug: Prednisolone

Granulocytes-Colony Stimulating Factor

Experimental group

Description:

Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days

Treatment:

Drug: Gcsf