NCT04066179

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

Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients -A Randomized Controlled Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholic Hepatitis

Interventions

Type	Name	Description
DRUG	Gcsf	Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days
DRUG	Prednisolone	Prednisolone 40 mg for initial 7 days

Timeline

• Start date: 2019-09-07
• Primary completion: 2021-02-27
• Completion: 2021-02-27
• First posted: 2019-08-26
• Last updated: 2019-09-09

Locations

1 site across 1 country: India