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.

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.

Study Overview

• Status: Unknown
• Conditions: Alcoholic Hepatitis
• Intervention / Treatment: Drug: Gcsf; Drug: Prednisolone

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
increase in Survival at 90 days in all the groups.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Anticipated): September 7, 2019
• Primary Completion (Anticipated): February 27, 2021
• Study Completion (Anticipated): February 27, 2021

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Hepatitis; Hepatitis A; Hepatitis, Alcoholic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone
• Other Study ID Numbers: ILBS-AH-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No