Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prednisolone+G-CSF Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days |
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
|
| Active Comparator: Prednisolone Prednisolone 40 mg/day for 7 days |
Drug: Prednisolone
Prednisolone 40 mg for initial 7 days
|
| Experimental: Granulocytes-Colony Stimulating Factor Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days |
Drug: Gcsf
Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days
|
Outcome Measures
Primary Outcome Measures
- increase in Survival at 90 days in all the groups. [90 days]
Secondary Outcome Measures
- Improvement in CTP (Child-Pugh Score) in all the groups. [Day 28]
CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.
- 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 28]
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.
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Liver and Biliary Sciences | New Delhi | Delhi | India | 110070 |
Sponsors and Collaborators
- Institute of Liver and Biliary Sciences, India
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ILBS-AH-03