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

Primary Purpose

Alcoholic Hepatitis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Gcsf
Prednisolone
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Hepatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Liver and Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Prednisolone+G-CSF

Prednisolone

Granulocytes-Colony Stimulating Factor

Arm Description

Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days

Prednisolone 40 mg/day for 7 days

Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days

Outcomes

Primary Outcome Measures

increase in Survival at 90 days in all the groups.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 14, 2019
Last Updated
September 5, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT04066179
Brief Title
Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.
Official Title
Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients -A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 7, 2019 (Anticipated)
Primary Completion Date
February 27, 2021 (Anticipated)
Study Completion Date
February 27, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prednisolone+G-CSF
Arm Type
Experimental
Arm Description
Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days
Arm Title
Prednisolone
Arm Type
Active Comparator
Arm Description
Prednisolone 40 mg/day for 7 days
Arm Title
Granulocytes-Colony Stimulating Factor
Arm Type
Experimental
Arm Description
Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days
Intervention Type
Drug
Intervention Name(s)
Gcsf
Intervention Description
Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Prednisolone 40 mg for initial 7 days
Primary Outcome Measure Information:
Title
increase in Survival at 90 days in all the groups.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Improvement in CTP (Child-Pugh Score) in all the groups.
Description
CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.
Time Frame
Day 28
Title
Improvement in CTP (Child-Pugh Score) in all the groups.
Description
CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.
Time Frame
Day 180
Title
Improvement in MELD (Model for End Stage Liver Disease) in all the groups.
Description
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.
Time Frame
Day 28
Title
Improvement in MELD (Model for End Stage Liver Disease) in all the groups.
Description
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.
Time Frame
Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Ajay Mishra, MD
Phone
01146300000
Email
ajaymishrapandit@gmail.com
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Ajay Mishra, MD
Phone
01146300000
Email
ajaymishrapandit@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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