NCT06470997 Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint Inhibitors
| NCT ID | NCT06470997 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Immune-mediated Hepatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2027-01-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-07-17 with a primary completion date of 2027-01-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.
Eligibility Criteria
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 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)
Contact & Investigator
Lucy MEUNIER, MD
STUDY DIRECTOR
University Hospital, Montpellier
Frequently Asked Questions
Who can join the NCT06470997 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immune-mediated Hepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06470997 currently recruiting?
Yes, NCT06470997 is actively recruiting participants. Contact the research team at lucy-meunier@chu-montpellier.fr for enrollment information.
Where is the NCT06470997 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT06470997 clinical trial?
NCT06470997 is sponsored by University Hospital, Montpellier. The principal investigator is Lucy MEUNIER, MD at University Hospital, Montpellier. The trial plans to enroll 60 participants.