drugset / Trial / NCT01820208

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

NCT01820208

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2014-03-01
Primary completion
2017-06-01
Completion
2017-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Granulocyte colony-stimulating factor Protein / enzyme biologic 5 ug/kg

Indications