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

This study is currently recruiting participants.
Verified December 2013 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01820208
First received: March 21, 2013
Last updated: April 17, 2014
Last verified: December 2013
  Purpose

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 Intervention
Severe Alcoholic Hepatitis
Drug: G-CSF
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • Proportion of Survival of subjects in both group [ Time Frame: 4 weeks and 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in Child's score in steroid unresponsive patients with severe alcoholic hepatitis patients [ Time Frame: 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Change in MELD score at 4 week and 12 weeks compared to baseline in both groups


Estimated Enrollment: 56
Study Start Date: March 2015
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01820208

Contacts
Contact: Dr Shasthry SM, MD +91-11-01146300000 shasthry@gmail.com

Locations
India
Institute of liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Shasthry SM, MD    +91-11-01146300000    shasthry@gmail.com   
Contact: Dr Ankit Bhardwaj    +91-11-01146300000    bhardwaj.ankit3@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01820208     History of Changes
Other Study ID Numbers: ILBS- AH-01
Study First Received: March 21, 2013
Last Updated: April 17, 2014
Health Authority: India: Ministry of Health

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
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014