Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Mycophenolate Mofetil and Rilonacept in Alcoholic Hepatitis
NCT01903798Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2014
- Primary completion
- Apr 2016
- Countries
- 1
- Sponsor
- Southern California Institute for Research and Education
- Modality
- Small Molecules, Fc-Fusion Proteins
- Conditions
- alcoholic hepatitis (AH)
01
Overview
Phase 2, randomised, open-label trial of mycophenolate mofetil and rilonacept in alcoholic hepatitis (AH) (4 arms), sponsored by Southern California Institute for Research and Education. Primary endpoint: Survival at Day 29 of the Assigned Treatment. Started Dec 2014; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
Prednisolone (Lille <0.45)
Continue Prednisolone 40 mg/day for 21 days.
Prednisolone + Rilonacept (Lille <0.45)
Continue Prednisolone + Rilonacept weekly for 21 days.
Prednisolone (Lille >0.45)
Stop all therapy (Standard of Care for non-responders).
Prednisolone + Mycophenolate (Lille >0.45)
Continue Prednisolone + Mycophenolate mofetil for 21 days.
03
Who it enrols
Patients with severe alcoholic hepatitis (Maddrey's DF > 32) and chronic alcohol consumption, without significant other liver disease, active infection, or renal insufficiency.
04
Endpoints
Primary
Survival at Day 29 of the Assigned Treatment
Secondary
Number of Patients Reported Ascites
Beyond the preview
Go deeper on NCT01903798.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT01903798.