Completed

Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis. - A Double Blind Randomized Control Trial.

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What is being tested

G-CSF

+ Placebo

Drug
Who is being recruted

Digestive System Diseases+6

+ Hepatitis

+ Liver Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2014
See protocol details

Summary

Principal SponsorInstitute of Liver and Biliary Sciences, India
Last updated: November 14, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2014

Actual date on which the first participant was enrolled.

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.

NCT01820208
Principal SponsorInstitute of Liver and Biliary Sciences, India
Last updated: November 14, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesHepatitisLiver DiseasesLiver Diseases, AlcoholicSubstance-Related DisordersAlcohol-Related DisordersAlcohol-Induced DisordersChemically-Induced DisordersHepatitis, Alcoholic

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Institute of liver and Biliary Sciences

New Delhi, IndiaOpen Institute of liver and Biliary Sciences in Google Maps
CompletedOne Study Center