Actively Recruiting
Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint Inhibitors
Led by University Hospital, Montpellier · Updated on 2025-11-21
60
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.
CONDITIONS
Official Title
Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 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 according to Common Terminology Criteria For Adverse Events (CTCAE)
- Treatment with corticosteroids or Ursodeoxycholic acid (UDCA) not started or started less than 30 days ago
- Patients over 18 years old with Primary Biliary Cholangitis (PBC), Autoimmune Hepatitis (AIH), or Primary Sclerosing Cholangitis (PSC)
- PBC diagnosis requires at least two of the following: chronic cholestasis over 6 months without bile duct abnormalities on ultrasound, M2 type anti-mitochondria antibodies above 1/40th, or characteristic histological lesions
- AIH diagnosis includes ALT greater than 5 times normal, Ig G increased 1.5 to 2 times normal, anti-smooth muscle antibodies 1/80 or higher, or marked interface hepatitis
- PSC diagnosis includes chronic cholestasis and typical bile duct abnormalities on cholangio-MRI without secondary causes
- Treatment with corticosteroids or UDCA not started or started less than 30 days ago
You will not qualify if you...
- Inability to follow the patient during the study period
- Liver biopsy not possible
- Diagnosis of hepatitis other than immune checkpoint inhibitor-induced or autoimmune types mentioned
- Failure to obtain consent
- Unemancipated minors or those unable to provide consent
- No affiliation to social security or equivalent
- Persons under judicial protection
- Participation in another research study with ongoing exclusion periods
- Pregnant or breastfeeding women
- New or old diagnosis at the time of a flare-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU de Montpellier
Montpellier, France, France, 34295
Actively Recruiting
Research Team
L
Lucy MEUNIER, MD
CONTACT
L
Lina HOUNTONDJI, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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