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Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis. - A Double Blind Randomized Control Trial.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Start Date
March 1, 2014
Primary Completion Date
June 1, 2017
Completion Date
June 1, 2017
Last Updated
November 14, 2017
28
ACTUAL participants
G-CSF
DRUG
Placebo
DRUG
Lead Sponsor
Institute of Liver and Biliary Sciences, India
NCT06155760
NCT04103840
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT02808663