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Completed

NCT Number: NCT01820208

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

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.

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Key information

Conditions

Severe Alcoholic Hepatitis Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Hepatitis Hepatitis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

G-CSF

Drug

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.

Placebo

Drug

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 outcomes

  1. Proportion of Survival of subjects in both group

    Time frame: 4 weeks and 12 weeks

Secondary outcomes

  1. Improvement in Child's score in steroid unresponsive patients with severe alcoholic hepatitis patients

    Time frame: 4 weeks and 12 weeks

    Change in child score at 4 week and 12 weeks compared to baseline in both groups.

  2. Improvement in MELD score in steroid unresponsive patients with severe alcoholic hepatitis patients

    Time frame: 4 weeks and 12 weeks

    Change in MELD score at 4 week and 12 weeks compared to baseline in both groups

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 28, 2013
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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