MedTrace Logo

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

NCT04810156 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-12-14

No results posted yet for this study

Summary

This clinical trial is to clarify and investigate the patterns of immune-related hepatitis and the optimal treatment choice for patients who are steroid-dependent. The project aims to prospectively characterize the various histopathological, biochemical, and phenotypical liver injury patterns induced by immune checkpoint inhibitors and the treatment responses to corticosteroids. Furthermore, the effect of adding a second-line immunosuppressive drug, either MMF in steroid-refractory or steroid-dependent cases will be explored and compared.

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.

Sponsors & Collaborators

  • Inge Marie Svane

    lead OTHER

Principal Investigators

  • Inge M Svane · Study Director, National Center for Cancer Immune Therapy, Dept. of Oncology, Hospital Herlev

  • Rikke B Holmstrøm · Ph.D student, National Center for Cancer Immune Therapy, Dept. of Oncology, Hospital Herlev

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2025-04-07
Completion
2025-11-07

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04810156 on ClinicalTrials.gov