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Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis

Primary Purpose

Severe Alcoholic Hepatitis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
G-CSF
Placebo
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 Severe 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 GI bleed
  • Hepatorenal syndrome
  • Patient unwilling
  • DF>120
  • Autoimmune hepatitis
  • Hepatitis B, Hepatitis C, HIV cases
  • Pregnancy

Sites / Locations

  • Institute of liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

G-CSF

Arm Description

Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses)

G-CSF would be given at a dose of 5 microgram/kg daily for 5 days followed by once in 3 days for a total of 12 doses.

Outcomes

Primary Outcome Measures

Proportion of Survival of subjects in both group

Secondary Outcome Measures

Improvement in Child's score in steroid unresponsive patients with severe alcoholic hepatitis patients
Change in child score at 4 week and 12 weeks compared to baseline in both groups.
Improvement in MELD score in steroid unresponsive patients with severe alcoholic hepatitis patients
Change in MELD score at 4 week and 12 weeks compared to baseline in both groups

Full Information

First Posted
March 21, 2013
Last Updated
November 11, 2017
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT01820208
Brief Title
Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis
Official Title
Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis. - A Double Blind Randomized Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
After successful screening, first the investigators first treat patients of severe alcoholic hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's score [>0.45] would be randomized into either placebo group or G-CSF group. Responders to steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non responders will be randomized to receive G-CSF for 28days.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses)
Arm Title
G-CSF
Arm Type
Experimental
Arm Description
G-CSF would be given at a dose of 5 microgram/kg daily for 5 days followed by once in 3 days for a total of 12 doses.
Intervention Type
Drug
Intervention Name(s)
G-CSF
Intervention Description
G-CSF would be given at a dose of 5 microgram/kg daily for 5 days followed by once in 3 days for a total of 12 doses.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses)
Primary Outcome Measure Information:
Title
Proportion of Survival of subjects in both group
Time Frame
4 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Improvement in Child's score in steroid unresponsive patients with severe alcoholic hepatitis patients
Description
Change in child score at 4 week and 12 weeks compared to baseline in both groups.
Time Frame
4 weeks and 12 weeks
Title
Improvement in MELD score in steroid unresponsive patients with severe alcoholic hepatitis patients
Description
Change in MELD score at 4 week and 12 weeks compared to baseline in both groups
Time Frame
4 weeks and 12 weeks

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 GI bleed Hepatorenal syndrome Patient unwilling DF>120 Autoimmune hepatitis Hepatitis B, Hepatitis C, HIV cases Pregnancy
Facility Information:
Facility Name
Institute of liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
30664267
Citation
Shasthry SM, Sharma MK, Shasthry V, Pande A, Sarin SK. Efficacy of Granulocyte Colony-stimulating Factor in the Management of Steroid-Nonresponsive Severe Alcoholic Hepatitis: A Double-Blind Randomized Controlled Trial. Hepatology. 2019 Sep;70(3):802-811. doi: 10.1002/hep.30516. Epub 2019 Mar 25.
Results Reference
derived

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Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis

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