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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

This trial does not accept healthy volunteers

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 population

CHILI group: patients with hepatitis induced by immune checkpoint inhibitors Control group: patients with idiopathic autoimmune hepatitis

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample collection

    Biological/Vaccine

    6 collections of 5mL blood samples as part of usual care (pre-inclusion visit at Day-7, inclusion visit at Day 0, visit1 at Day 14, visit2 at Day 28, visit3 at Day 90, visit4 at 6 months) and 5 blood sample collections of 5 mL for proteomic analysis in the context of research (inclusion visit at Day 0, visit1 at Day 14, visit2 at Day 28, visit3 at Day 90, visit4 at 6 months)

  • Liver biopsy

    Procedure/Surgery

    1 liver biopsy performed as part of routine care and 1 additional sample for research: transparietal needle biopsy under ultrasound identification under local anesthesia by a radiologist, 1 to 2 cm per core taken, 2 cores are taken.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: CHILI : hepatitis induced by immune checkpoint inhibitors2 interventions
Group B: Control group: idiopathic autoimmune hepatitis2 interventions

Trial outcomes

Primary outcomes

1

Determination of the area under the ROC (Receiver Operation characteristic) curve for hepatitis.

Sensitivity/specialty curve of blood biomarkers identification and expression level by proteomic analysis, specific to immunotherapy-induced hepatitis (CHILI group), versus idiopathic autoimmune hepatitis (control group).

Time frame
Baseline

Secondary outcomes

1

Determination of the area under the ROC (Receiver Operation characteristic) curve for treatment response

Sensitivity/specialty curve of blood biomarkers identification and expression level by proteomic analysis, specific to response to treatments corticosteroids, UDCA (Ursodeoxycholic acid) established as part of the care).

Time frame
Baseline, day 14, day 28, month 3, month 6
2

Responses to treatments

Response to corticosteroid and UDCA (Ursodeoxycholic acid) treatments being defined as a reduction in liver tests of 50%

Time frame
Day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov
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