An interventional study of Gcsf and Prednisolone in Alcoholic Hepatitis, sponsored by Institute of Liver and Biliary Sciences, India. Status unknown at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-09.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 126 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days
Drug: Gcsf · Drug: Prednisolone
Prednisolone 40 mg/day for 7 days
Drug: Prednisolone
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
Prednisolone 40 mg for initial 7 days
increase in Survival at 90 days in all the groups.
Time frame: 90 days
Improvement in CTP (Child-Pugh Score) in all the groups.
CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.
Time frame: Day 28
Improvement in CTP (Child-Pugh Score) in all the groups.
CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.
Time frame: Day 180
Improvement in MELD (Model for End Stage Liver Disease) in all the groups.
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.
Time frame: Day 28
Improvement in MELD (Model for End Stage Liver Disease) in all the groups.
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.
Time frame: Day 180
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institute of Liver and Biliary Sciences, India