Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.
1 other identifier
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2019
CompletedFirst Posted
Study publicly available on registry
August 26, 2019
CompletedStudy Start
First participant enrolled
September 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2021
CompletedSeptember 9, 2019
August 1, 2019
1.5 years
August 14, 2019
September 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
increase in Survival at 90 days in all the groups.
90 days
Secondary Outcomes (4)
Improvement in CTP (Child-Pugh Score) in all the groups.
Day 28
Improvement in CTP (Child-Pugh Score) in all the groups.
Day 180
Improvement in MELD (Model for End Stage Liver Disease) in all the groups.
Day 28
Improvement in MELD (Model for End Stage Liver Disease) in all the groups.
Day 180
Study Arms (3)
Prednisolone+G-CSF
EXPERIMENTALPrednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days
Prednisolone
ACTIVE COMPARATORPrednisolone 40 mg/day for 7 days
Granulocytes-Colony Stimulating Factor
EXPERIMENTALGranulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days
Interventions
Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days
Eligibility Criteria
You may qualify if:
- Severe alcoholic hepatitis patients \[Maddrey's score \> 32\] aged between 18 to 65 years.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2019
First Posted
August 26, 2019
Study Start
September 7, 2019
Primary Completion
February 27, 2021
Study Completion
February 27, 2021
Last Updated
September 9, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share