At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Obtaining biological samples (diagnostic test)
- How long the study runs
- Study runs about 68 months (dates as stated)
- About the drug or intervention
- Obtaining biological samples — diagnostic test: Biological samples (blood, urine, stool).
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 160
- Started
- 2020-10-13
- Last checked
- 2025-09
Plain English Summary
What is this study?
- • Testing a new treatment for immune-mediated hepatitis
- • Clinical study - 160 participants
- • In this multi-center prospective observational study, the investigators plan to identify the incidence and risk factors for checkpoint inhibitor-induced liver injury and characterize biochemical, genetic, immunological, and histological features associated with it
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with immune-mediated hepatitis
Where?
- • Nottingham - University of Nottingham
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
In this multi-center prospective observational study, the investigators plan to identify the incidence and risk factors for checkpoint inhibitor-induced liver injury and characterize biochemical, genetic, immunological, and histological features associated with it.
More detail
Checkpoint inhibitor-induced liver injury (ChILI) is a new incompletely understood category of hepatotoxicity which is distinct from other types of drug-induced liver injury (DILI) such as direct or idiosyncratic DILI. The data regarding the incidence and risk factors is lacking. Therefore, 'in-depth phenotyping' together with data from the control group exposed to checkpoint inhibitors (CPI) is necessary to develop refined algorithms incorporating CPI-related factors, host genetic and environmental risk factors that would enable pre-empting ChILI. The aim of the study is to enroll two deeply phenotyped cohorts (patients who developed ChILI and patients who are starting checkpoint inhibitors) and obtain biological samples at multiple time points.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Both patient groups and control group:
- ✓ChILI group:
- ✓Patients who developed checkpoint inhibitor-induced liver injury and meet the following criteria:
- ✓Meets one of the following analytical thresholds at enrolment (visit 1)
- ✓Alanine transaminase (liver enzymes) exceeding 5 times the upper limit of normal (ULN) OR
Who cannot take part
- ✗Patients who are treated with cytotoxic drug treatment concurrently with checkpoint inhibitors.
- ✗On the judgment of chief investigator that the person has certain alternative explanations to the acute event...
See the full criteria
Where Is This Study? (1 UK site)
University of Nottingham
Nottingham NG72RD, United Kingdom
How to Get in Touch
Guruprasad Padur Aithal, MBBS, FRCP, PhD
Sponsor contactCONTACT
Edmond Atallah, M.D, MRCP(UK)
Sponsor contactCONTACT
