Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066179
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:
The patients of Severe Alcoholic Hepatitis (SAH) will be included in study based on inclusion and exclusion criteria. The patients will be then randomized in 3 groups for therapy. They will receive either steroid or Granulocyte-Colony Stimulating Factor (GCSF) or both. They will be followed for atleast 90 days for improvements in symptoms and various predefined parameters. Primary outcome will be improvement in survival at 90 Days. Patients will be monitored at every follow up for disease progression and complications of therapy. The study results will be analyzed for differences in survival rate and complications in different groups to propose new therapeutic guideline in SAH patients.

Condition or disease Intervention/treatment Phase
Alcoholic Hepatitis Drug: Gcsf Drug: Prednisolone Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients -A Randomized Controlled Trial.
Estimated Study Start Date : September 7, 2019
Estimated Primary Completion Date : February 27, 2021
Estimated Study Completion Date : February 27, 2021


Arm Intervention/treatment
Experimental: Prednisolone+G-CSF
Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days
Drug: Gcsf
Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days

Drug: Prednisolone
Prednisolone 40 mg for initial 7 days

Active Comparator: Prednisolone
Prednisolone 40 mg/day for 7 days
Drug: Prednisolone
Prednisolone 40 mg for initial 7 days

Experimental: Granulocytes-Colony Stimulating Factor
Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days
Drug: Gcsf
Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days




Primary Outcome Measures :
  1. increase in Survival at 90 days in all the groups. [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Improvement in CTP (Child-Pugh Score) in all the groups. [ Time Frame: Day 28 ]
    CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.

  2. Improvement in CTP (Child-Pugh Score) in all the groups. [ Time Frame: Day 180 ]
    CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.

  3. Improvement in MELD (Model for End Stage Liver Disease) in all the groups. [ Time Frame: Day 28 ]
    A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list. A MELD score is a number that ranges from 6 to 40, based on lab tests.

  4. Improvement in MELD (Model for End Stage Liver Disease) in all the groups. [ Time Frame: Day 180 ]
    A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list. A MELD score is a number that ranges from 6 to 40, based on lab tests.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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 Gastrointestinal bleed
  • Hepatorenal syndrome
  • Patient unwilling
  • Discriminant Function >90
  • Autoimmune hepatitis
  • Hepatitis B, Hepatitis C, Human immunodeficiency Virus cases
  • Pregnancy
  • Hemophagocytic lymphohistiocytosis (HLH)
  • Hb<8 and baseline White Blood Cell>25000

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): NCT04066179


Contacts
Layout table for location contacts
Contact: Dr Ajay Mishra, MD 01146300000 ajaymishrapandit@gmail.com

Locations
Layout table for location information
India
Institute of Liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Ajay Mishra, MD    01146300000    ajaymishrapandit@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Layout table for additonal information
Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT04066179    
Other Study ID Numbers: ILBS-AH-03
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis
Hepatitis, Alcoholic
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
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents