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

RecruitingOBSERVATIONAL
Enrollment

63

Participants

Timeline

Start Date

August 25, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Immune Related Adverse EventsImmune-Mediated HepatitisCancer
Interventions
DRUG

Low-dose corticosteroids for immune-related hepatitis grade 3

Prednisolone 0.5-1 mg/kg orally for grade 3 IR-hepatitis; adjusted based on liver function; treatment per local standard of care.

DRUG

Low-dose corticosteroids for immune-related hepatitis grade 2

Hold immunotherapy and reassess liver function at the treating physician's discretion. If liver function tests persistently worsen or continue to rise, consider administering prednisolone at 0.5 mg/kg body weight

Trial Locations (2)

4031

RECRUITING

University Hospital Basel, Basel

SW3 6JJ

NOT_YET_RECRUITING

Royal Marsden Hospital, London

All Listed Sponsors
collaborator

Royal Marsden NHS Foundation Trust

OTHER

collaborator

Odense University Hospital

OTHER

collaborator

UMC Utrecht

OTHER

lead

University Hospital, Basel, Switzerland

OTHER

NCT07167251 - Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids | Biotech Hunter | Biotech Hunter