Immune-Mediated CholestasisPhase 2CHILURSONCT07378761
Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis
A Phase 2 study testing UDCA (Ursodeoxycholic acid) and Corticosteroids (Reference Treatment) in people with Immune-Mediated Cholestasis, run by University Hospital, Montpellier at 6 sites in France.
Trial summary
The clinical trial aims to compare the effectiveness of ursodeoxycholic acid (UDCA) to corticosteroids in treating cholestatic hepatitis induced by immune checkpoint inhibitors (ICIs) over a 21-day period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune-Mediated Cholestasis
- What is being tested?
- UDCA (Ursodeoxycholic acid) and Corticosteroids (Reference Treatment)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 6 sitesFrance
- Study dates
- 25 Jun 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years old
- Any type of cancer except hepatocellular or cholangiocarcinoma
- At least one ICI injection
- Cholestatic hepatitis Grade CTC-AE 3 or 4
Who cannot join
- Ongoing corticosteroids treatment
- Other causes of hepatitis
- Cirrhosis
- ICI for hepatocellular carcinoma or cholangiocarcinoma
- Biliary obstruction
- Medical contraindication to corticosteroids or UDCA
Show all 15Show fewer
- Mixed or hepatocellular hepatitis
- Total bilirubin > 1,5 ULN, Prothrombin rate < 70%
- Medical contraindication to MRI or liver biopsy
- Oher serious side effects requiring corticosteroids
- Pregnant and breast-feeding patients
- Patients under articles L1121-5 to 8 of the public health code
- Lack of informed consent
- Patients not affiliated with French social security system
- Patients uncapable of understanding french
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Not yet recruiting
CHU Bordeaux
Bordeaux
Dr. CHERMAK
Faiza CHERMAK, MD
- Recruiting
HCL Croix Rousse
Lyon
Dr. LEBOSSE
Fanny LEBOSSE, MD
- Recruiting
CHU Montpellier
Montpellier
Dr. MEUNIER, +33467330224, lucy.meunier@chu-montpellier.fr
Lucy MEUNIER, MD
- Not yet recruiting
APHP Paul Brousse
Paris
Dr. DEMARTIN
Eléonora DE MARTIN, MD
- Not yet recruiting
CHU Poitiers
Poitiers
Dr. ROLLE
Valentin ROLLE, MD
- Not yet recruiting
CHU Toulouse
Toulouse
Dr. RIVET
Valérian RIVET, MD
About this study
Official title: Efficacy of Ursodeoxycholic Acid Versus Corticosteroids for the Treatment of Cholestatic Hepatitis Secondary to Immunotherapy: A Multicenter, Controlled, Randomized, Open Trial
The clinical trial aims to compare the effectiveness of ursodeoxycholic acid (UDCA) to corticosteroids in treating cholestatic hepatitis induced by immune checkpoint inhibitors (ICIs) over a 21-day period.
The trial presents a detailed scientific justification for comparing UDCA to corticosteroids, describing the treatment and detailing the follow-up procedures. It hypothesizes that UDCA could be superior to corticosteroids for treating ICI-related cholestatic hepatitis, based on its established use in primary biliary cholangitis and a favorable tolerance profile compared to corticosteroids.
- Conditions
- Immune-Mediated Cholestasis
- Being tested
- UDCA (Ursodeoxycholic acid), Corticosteroids (Reference Treatment)
- Keywords
- DILI, Immune checkpoint inhibitors, Cancer, Cholestatic hepatitis
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UDCA (Ursodeoxycholic acid)Drug
Ursodeoxycholic acid (UDCA) will be administered orally at an initial dose of 13-15 mg/kg/day, divided into two daily doses. After assessment of the primary endpoint at Day 21, UDCA will be continued for a total treatment duration of 6 months. In case of absence of treatment response, defined as no decrease of alkaline phosphatase and/or gamma-glutamyl transferase levels of at least 25% compared with baseline, corticosteroids which represent the reference treatment, will be added at a dose of 0.5-1 mg/kg.
Corticosteroids (Reference Treatment)Drug
Corticosteroids will be administered orally at a dose of 0.5-1 mg/kg/day for 21 days, followed by a tapering schedule of 10 mg per week until treatment discontinuation. At Day 21, if there is no adequate response (defined as less than 25% decrease in alkaline phosphatase and/or gamma-glutamyl transferase from baseline), the corticosteroid taper will continue and ursodeoxycholic acid (UDCA) will be added at a dose of 13-15 mg/kg/day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients randomized to the experimental arm will receive ursodeoxycholic acid (UDCA) as initial treatment for hepatitis. After evaluation of the primary endpoint at Day 21, UDCA treatment will be continued for a total duration of 6 months. In case of lack of response to UDCA, patients will continue UDCA and will additionally receive corticosteroids which represent the reference treatment. Receives: Drug: UDCA (Ursodeoxycholic acid) |
| Control arm | Active comparator | Patients randomized to the control arm will receive the reference treatment, corticosteroids. Corticosteroids will be given at a dose of 0.5-1 mg/kg/day for 21 days, followed by tapering in weekly steps of 10 mg until treatment discontinuation. At Day 21, in case of lack of treatment response, defined as no decrease of alkaline phosphatase and/or gamma-glutamyl transferase levels of at least 25% compared with baseline, corticosteroid tapering will continue, and ursodeoxycholic acid (UDCA) will be added at a dose of 13-15 mg/kg/day. Receives: Drug: Corticosteroids (Reference Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of at least 25% in liver function tests on day 21 after randomization
The rate of patients showing an improvement of at least 25% in liver function tests (alkaline phosphatase and/or gamma-GT) on Day 21 after randomization.
Measured: 21 days after randomization
Secondary outcomes (4)
Rate of Hepatitis Resolution at 6 Months
Rate of patients with resolution of hepatitis, defined as hepatitis grade ≤ 1 according to the current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), at 6 months after randomization.
Measured: 6 Months after randomization
Time to Hepatitis Resolution
Time to hepatitis resolution, defined as the time from the date of randomization to the date of hepatitis resolution (grade ≤ 1). Hepatitis severity will be graded according to the current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Measured: From Randomization to end of follow-up at 12 months
Tolerance to UDCA and/or Corticosteroids
Tolerance to ursodeoxycholic acid (UDCA) and/or corticosteroids will be evaluated through the assessment of adverse events. Adverse events will be collected throughout the study and graded according to the current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Measured: From treatment initiation following the randomization to end of follow-up at 12 months
Resumption of immunotherapy
Rate of patients in whom resumption of immunotherapy was possible after hepatitis within 12 months after randomization
Measured: Within 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start25 Jun 2026
- Primary completionJan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune-Mediated CholestasisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Meunier, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378761
- Sponsor's protocol ID
- RECHMPL24_0328
- Other IDs
- 2025-521317-50-00, 2025
- Acronym
- CHILURSO
- Status last verified
- Jun 2026
- First submitted
- 22 Jan 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ursodeoxycholic Acid Versus Corticosteroids for the Treatment of Cholestatic Hepatitis Secondary to Immunotherapy: A Multicenter, Controlled, Randomized, Open Trial
- ClinicalTrials.gov ID
- NCT07378761
- Acronym / sponsor ID
- CHILURSO / RECHMPL24_0328
- Conditions
- Immune-Mediated Cholestasis
- Keywords
- DILI, Immune checkpoint inhibitors, Cancer, Cholestatic hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical trial aims to compare the effectiveness of ursodeoxycholic acid (UDCA) to corticosteroids in treating cholestatic hepatitis induced by immune checkpoint inhibitors (ICIs) over a 21-day period.
The trial presents a detailed scientific justification for comparing UDCA to corticosteroids, describing the treatment and detailing the follow-up procedures. It hypothesizes that UDCA could be superior to corticosteroids for treating ICI-related cholestatic hepatitis, based on its established use in primary biliary cholangitis and a favorable tolerance profile compared to corticosteroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: UDCA (Ursodeoxycholic acid)Patients randomized to the experimental arm will receive ursodeoxycholic acid (UDCA) as initial treatment for hepatitis. After evaluation of the primary endpoint at Day 21, UDCA treatment will be continued for a total duration of 6 months. In case of lack of response to UDCA, patients will continue UDCA and will additionally receive corticosteroids which represent the reference treatment. |
| Control arm | Active comparator | Drug: Corticosteroids (Reference Treatment)Patients randomized to the control arm will receive the reference treatment, corticosteroids. Corticosteroids will be given at a dose of 0.5-1 mg/kg/day for 21 days, followed by tapering in weekly steps of 10 mg until treatment discontinuation. At Day 21, in case of lack of treatment response, defined as no decrease of alkaline phosphatase and/or gamma-glutamyl transferase levels of at least 25% compared with baseline, corticosteroid tapering will continue, and ursodeoxycholic acid (UDCA) will be added at a dose of 13-15 mg/kg/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥18 years old
- Any type of cancer except hepatocellular or cholangiocarcinoma
- At least one ICI injection
- Cholestatic hepatitis Grade CTC-AE 3 or 4
Key exclusion criteria (15 listed)
- Ongoing corticosteroids treatment
- Other causes of hepatitis
- Cirrhosis
- ICI for hepatocellular carcinoma or cholangiocarcinoma
- Biliary obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UDCA (Ursodeoxycholic acid)Ursodeoxycholic acid (UDCA) will be administered orally at an initial dose of 13-15 mg/kg/day, divided into two daily doses. After assessment of the primary endpoint at Day 21, UDCA will be continued for a total treatment duration of 6 months. In case of absence of treatment response, defined as no decrease of alkaline phosphatase and/or gamma-glutamyl transferase levels of at least 25% compared with baseline, corticosteroids which represent the reference treatment, will be added at a dose of 0.5-1 mg/kg. | Drug | Experimental arm |
| Corticosteroids (Reference Treatment)Corticosteroids will be administered orally at a dose of 0.5-1 mg/kg/day for 21 days, followed by a tapering schedule of 10 mg per week until treatment discontinuation. At Day 21, if there is no adequate response (defined as less than 25% decrease in alkaline phosphatase and/or gamma-glutamyl transferase from baseline), the corticosteroid taper will continue and ursodeoxycholic acid (UDCA) will be added at a dose of 13-15 mg/kg/day. | Drug | Control arm |
Primary outcome
Improvement of at least 25% in liver function tests on day 21 after randomization
Time frame: 21 days after randomization
The rate of patients showing an improvement of at least 25% in liver function tests (alkaline phosphatase and/or gamma-GT) on Day 21 after randomization.
4 secondary outcomes
Rate of Hepatitis Resolution at 6 Months
Time frame: 6 Months after randomization
Time to Hepatitis Resolution
Time frame: From Randomization to end of follow-up at 12 months
Tolerance to UDCA and/or Corticosteroids
Time frame: From treatment initiation following the randomization to end of follow-up at 12 months
Resumption of immunotherapy
Time frame: Within 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Meunier principal investigator
University Hospital, Montpellier
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UDCA (Ursodeoxycholic acid) and Corticosteroids (Reference Treatment) in people with Immune-Mediated Cholestasis, run by University Hospital, Montpellier at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. MEUNIER (+33467330224, lucy.meunier@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of at least 25% in liver function tests on day 21 after randomization (time frame: 21 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.