Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.
- Registration Number
- NCT04066179
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 126
- Severe alcoholic hepatitis patients [Maddrey's score > 32] aged between 18 to 65 years.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Granulocytes-Colony Stimulating Factor Gcsf Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days Prednisolone+G-CSF Gcsf Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days Prednisolone+G-CSF Prednisolone Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days Prednisolone Prednisolone Prednisolone 40 mg/day for 7 days
- Primary Outcome Measures
Name Time Method increase in Survival at 90 days in all the groups. 90 days
- Secondary Outcome Measures
Name Time Method Improvement in CTP (Child-Pugh Score) in all the groups. Day 180 CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.
Improvement in MELD (Model for End Stage Liver Disease) in all the groups. Day 180 A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list. A MELD score is a number that ranges from 6 to 40, based on lab tests.
Trial Locations
- Locations (1)
Institute of Liver and Biliary Sciences
🇮🇳New Delhi, Delhi, India