Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint Inhibitors (NCT06470997) | Clinical Trial Compass
RecruitingNot Applicable
Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint Inhibitors
France60 participantsStarted 2024-07-17
Plain-language summary
Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria for patients in the CHILI group:
* 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
* Grade 3 or 4 hepatitis: increase in transaminases and/or alkaline phosphatases ≥ 5 x Upper Limit of Normal (ULN) or total bilirubin ≥ 3
Inclusion criteria for patients in the control group:
* Patient \> 18 years old
* Patient suffering from Primary Biliary Cholangitis (PBC)\* or Autoimmune Hepatitis (AIH)\*\* or Primary Sclerosing Cholangitis (PSC) \*\*\*
Primary Biliary Cholangitis (PBC)\* diagnosis :
Association of at least 2 of the following 3 criteria :
* Cholestasis (PAL \> 1.5N, Gamma GT \> 3N) chronic (\> 6 months) without ultrasound abnormality of the bile ducts.
* M2 type anti-mitochondria Ab \> 1/40th
* Characteristic histological lesions (non-suppurative destructive cholangitis) or compatible (portal inflammation, granulomas, ductular proliferation, ductopenia, cholestasis).
\*\* AIH diagnosis : ALT \> 5 N / Ig G \> 1.5 - 2 N or anti-smooth muscle ≥ 1/80 / Interface hepatitis of marked intensity The Hepactic Activity Index (HAI) score makes it possible to confirm the diagnosis when all the diagnostic criteria are not met.
\*\*\* PSC …
What they're measuring
1
Determination of the area under the ROC (Receiver Operation characteristic) curve for hepatitis.