drugset / Trial / NCT01820208
Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 5 ug/kg | — |