Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint

Status: Recruiting
Location: See location...
Intervention Type: Biological, Procedure
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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 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

Locations
Other Locations
France
CHU de Montpellier
RECRUITING
Montpellier
Contact Information
Primary
Lucy MEUNIER, MD
lucy-meunier@chu-montpellier.fr
0467330224
Backup
Lina HOUNTONDJI, MD
l-hountondji@chu-montpellier.fr
Time Frame
Start Date: 2024-07-17
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 60
Treatments
CHILI : hepatitis induced by immune checkpoint inhibitors
Patient with immunotherapy-induced hepatitis
Control group: idiopathic autoimmune hepatitis
Patient with idiopathic autoimmune hepatitis
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov