๐ฌIn plain words
What the trial is, and whether it could suit you
Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ 5 x Upper Limit of Normal (ULN) or total bilirubin โฅ 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 โฅ 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 diagnosis: presence of chronic cholestasis (alkaline phosphatase \> 1.5 N or GGT \> 3 N) and typical abnormalities of the bile ducts on cholangio-MRI (Magnetic Resonance Imaging), and in the absence of cause of secondary sclerosing cholangitis
* Treatment with corticosteroids or Ursodeoxycholic acid (UDCA) not initiated, or started less than 30 days ago
Non-inclusion criteria:
* Impossibility of following the patient during the study period
* Liver biopsy not possible
* Other hepatitis diagnoses
* Failure to obtain consent
* Unemancipated minors, people unable to express their consent
* Non-affiliation to a social security or equivalent scheme,
* Persons placed under judicial protection,
* Person participating in another research including a period of exclusion still in progress.
* Pregnant or breastfeeding women
* De novo or old diagnosis (at the time of a flare-up)