Health Trials

Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint Inhibitors

ConditionImmune-mediated Hepatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.

Eligibility criteria

Qualifiers

Patient > 18 years old

Patient treated with immune checkpoint inhibitors (ICI) alone or in combination

Patient suffering from Hepatitis secondary to immune checkpoint inhibitors (ICI) grade 3 or 4 Common Terminology Criteria For Adverse Events (CTCAE)*

Treatment with corticosteroids or Ursodeoxycholic acid (UDCA) not started, or started less than 30 days ago

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Blood sample collection
  • Liver biopsy

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov