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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014