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

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ClinicalTrials.gov Identifier: NCT01820208
Recruitment Status : Completed
First Posted : March 28, 2013
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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.

Condition or disease Intervention/treatment Phase
Severe Alcoholic Hepatitis Drug: G-CSF Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis. - A Double Blind Randomized Control Trial.
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 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)
Drug: G-CSF
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.
Experimental: G-CSF
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.
Drug: 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)



Primary Outcome Measures :
  1. Proportion of Survival of subjects in both group [ Time Frame: 4 weeks and 12 weeks ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820208


Locations
India
Institute of liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01820208     History of Changes
Other Study ID Numbers: ILBS- AH-01
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs