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

Alcoholic Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04066179
• Other study ID #: ILBS-AH-03
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2019
• Est. completion date: February 27, 2021

Study information

• Verified date: August 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Ajay Mishra, MD
• Phone: 01146300000
• Email: ajaymishrapandit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: February 27, 2021
• Est. primary completion date: February 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Intervention

Drug:
• Gcsf
Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days
• Prednisolone
Prednisolone 40 mg for initial 7 days

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase in Survival at 90 days in all the groups.		90 days
Secondary	Improvement in CTP (Child-Pugh Score) in all the groups.	CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.	Day 28
Secondary	Improvement in CTP (Child-Pugh Score) in all the groups.	CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.	Day 180
Secondary	Improvement in MELD (Model for End Stage Liver Disease) in all the groups.	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.	Day 28
Secondary	Improvement in MELD (Model for End Stage Liver Disease) in all the groups.	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.	Day 180