Treatment Efficacy of Corticosteroids and Mycophenolate Mofetil in Patients With Immune Related Hepatitis

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 7, 2021

Primary Completion Date

April 7, 2025

Study Completion Date

November 7, 2025

Conditions
Hepatitis, Drug-Induced
Interventions
DRUG

Mycophenolate Mofetil

Day 1: MMF 500 mg twice a day Day 2: MMF 1000 mg twice a day

DRUG

Solu-Medrol

2 mg/kg/day

DRUG

Ursodeoxycholic acid

Patients with mixed or cholestatic liver injury pattern will also be administrated peroral UDCA according to weight

DRUG

Prednisone tablet

Shift from solu-medrol IV to peroral prednisolon. A tapering plan will be performed.

Trial Locations (5)

2100

RECRUITING

Rigshospitalet, Copenhagen

2730

RECRUITING

Herlev University Hospital, Herlev

5000

RECRUITING

Odense University Hospital, Odense

8000

RECRUITING

Aarhus University Hospital, Aarhus

9000

NOT_YET_RECRUITING

Aalborg University Hospital, Aalborg

All Listed Sponsors
lead

Inge Marie Svane

OTHER