Clinical Trial

Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids

Study acronym: MIRA-HEP
Recruiting
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Summary
This study evaluates the effectiveness of low-dose corticosteroids in managing grade 2-3 immune-related hepatitis in cancer patients treated with immune checkpoint inhibitors. It aims to determine whether of 0.5-1miligram per kilogram bodyweight prednisolone is sufficient to manage immune-related hepatitis without the need for dose escalation or additional immunosuppressive therapy.
Trial Details
NCT Number NCT07167251
Lead Sponsor University Hospital, Basel, Switzerland
Collaborators: Royal Marsden NHS Foundation Trust, Odense University Hospital, UMC Utrecht
Conditions Immune Related Adverse Events, Immune-Mediated Hepatitis, Cancer
Enrollment 63 participants
Start Date 2025-08-25
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-11