Hepatitis, Drug-InducedPhase 2I-HEPNCT04810156
Treatment Efficacy of Corticosteroids and Mycophenolate Mofetil in Patients With Immune Related Hepatitis
A Phase 2 study testing Mycophenolate Mofetil, Solu-Medrol and Ursodeoxycholic acid in people with Hepatitis, Drug-Induced, run by Inge Marie Svane at 5 sites in Denmark.
Trial summary
This clinical trial is to clarify and investigate the patterns of immune-related hepatitis and the optimal treatment choice for patients who are steroid-dependent. The project aims to prospectively characterize the various histopathological, biochemical, and phenotypical liver injury patterns induced by immune… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis, Drug-Induced
- What is being tested?
- Mycophenolate Mofetil, Solu-Medrol and Ursodeoxycholic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesDenmark
- Study dates
- 7 Apr 2021to 7 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Cohort A:
- Abnormal liver parameters equal to ≥ grade 3 ir-hepatitis defined as; AST/ALT/ALP >5 x ULN, INR ≥ 2.5 x ULN, or bilirubin > 3.0 x ULN
- Cohort B:
- Patients who recur during or within one months of prednisolone tapering of ≥2 ir-hepatitis equal to AST/ALT ≥3 x ULN, ALP ≥2.5 x ULN, INR ≥ 1.5 x ULN, or bilirubin ≥ 3.0 x ULN
- Cohort A and Cohort B
- Histologically confirmed solid cancer
Show all 12Show fewer
- Treatment with cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) or Programmed Cell Death-1 (PD-1)/Programmed Cell Death Ligand-1 (PD-L1) inhibitor or a combination of CTLA-4 plus PD-1 inhibitors within 6 months
- Age: ≥ 18 years
- Women of childbearing potential: Negative serum pregnancy test and must use effective contraception. This applies from screening and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered effective contraceptives
- Men with female partner of childbearing potential must use effective contraception from screening and until 6 months after treatment. Effective contraceptives are as described above for the female partner. In addition, documented vasectomy and sterility or double barrier contraception are considered effective contraceptives
- Signed statement of consent after receiving oral and written study information
- Willingness to participate in the planned treatment and follow-up and capable of handling toxicities.
Who cannot join
- Concomitant chemotherapy treatment or tyrosine kinases or angiogenesis inhibitors
- Concomitant immunosuppressive medication except prednisolone
- Patients with hepatocellular carcinoma
- Known hypersensitivity to one of the active drugs or excipients
- Uncontrolled infection
- Acute viral hepatitis
Show all 10Show fewer
- Any medical condition that will interfere with patient compliance or safety
- Simultaneous treatment with other experimental drugs or other anticancer drugs
- Pregnant or breastfeeding females
- Phenylketonuria
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Not yet recruiting
Aalborg University Hospital
Aalborg, 9000
Peter Holland-Fischer, Ph.d, MD
- Recruiting
Aarhus University Hospital
Aarhus, 8000
Niels Kristian Aagaard, Ph.d., DMsc, MD
- Recruiting
Rigshospitalet
Copenhagen, 2100
Peter N Bjerring, Ph.D. MD
- Recruiting
Herlev University Hospital
Herlev, Copenhagen, 2730
Rikke B Holmstrøm, MD, +4538682971, rikke.boedker.holmstroem@regionh.dk
Ane S Teisner, MD
- Recruiting
Odense University Hospital
Odense, 5000
Annette D Fialla, Ph.d, MD
About this study
Official title: A National Prospective Study of Patients With Hepatitis Induced by Immune Checkpoint Inhibitors; Characterization of Liver Injury, Outcome of Therapy and Randomization to Either Prednisolone or Mycophenolate Mofetil Treatment in Case of Relapse
This clinical trial is to clarify and investigate the patterns of immune-related hepatitis and the optimal treatment choice for patients who are steroid-dependent. The project aims to prospectively characterize the various histopathological, biochemical, and phenotypical liver injury patterns induced by immune checkpoint inhibitors and the treatment responses to corticosteroids. Furthermore, the effect of adding a second-line immunosuppressive drug, either MMF in steroid-refractory or steroid-dependent cases will be explored and compared.
Read the detailed description
The number of patients treated with immune checkpoint inhibitors (ICI) is expanding worldwide due to an increasing number of indications, including additional types of cancer, combination of ICI with other antineoplastic therapies and have recently moved into the adjuvant setting. According to clinical trial material, almost all patients in ICI treatment will eventually develop any grade of an adverse event, here, estimated in up to 90 percent of treated patients. Around 10-30 percent of ICI-treated patients will show signs of liver injury related to ICI treatment and will be diagnosed with immune-related hepatitis. The treatment hereof should include observation and medium-dose steroids in low-grade asymptomatic patients (grade ≤ 2 ir-hepatitis) and high-dose steroids in higher grades according to the current European and American guidelines. However, up to 25 percent of patients with ir-hepatitis may not respond properly to steroids due to primary resistance or relapse during tapering. These patients should be offered a second-line immunosuppressive treatment. The present recommendation for patients with steroid-dependent ir-hepatitis is based on the case series and includes immunosuppressive treatment with mycophenolate mofetil (MMF). To date, no evidence exists for which second-line treatment to choose.
However, in the clinic, the initiation of MMF may be delayed, meanwhile, patients are typically treated with an increased dose of steroids. In some cases, an increased dose of steroids with prolonged tapering can be sufficient. We want to explore if increased doses of steroids or adding MMF is the best strategy for relapse of hepatitis.
In addition, patients with signs of biliary or mixed liver injury may benefit from adding ursodeoxycholic acid (UDCA).
- Conditions
- Hepatitis, Drug-Induced
- Being tested
- Mycophenolate Mofetil, Solu-Medrol, Ursodeoxycholic acid, Prednisone tablet
- Keywords
- Hepatitis, Immunotherapy, Cancer, Adverse events, Immune checkpoint inhibitors, Steroid-refractory, Steroid-dependent
- Medical subject headings
- Chemical and Drug Induced Liver Injury, Hepatitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Cellcept, Myfenax
Day 1: MMF 500 mg twice a day Day 2: MMF 1000 mg twice a day
Solu-MedrolDrug
Also called Methylprednisolone, Medrol, Corticosteroids, Steroid
2 mg/kg/day
Ursodeoxycholic acidDrug
Also called ursochol
Patients with mixed or cholestatic liver injury pattern will also be administrated peroral UDCA according to weight
Prednisone tabletDrug
Also called steroid, Corticosteroids
Shift from solu-medrol IV to peroral prednisolon. A tapering plan will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Steroids and MMF in grade 3-4 ir-hepatitis | Active comparator | Patients with ≥ 3 grade ir-hepatitis will be treated with high-dose steroids 2 mg/kg/day intravenously. A diagnostic liver biopsy will be taken. Patients with mixed or cholestatic liver injury patterns will be added UDCA. Treatment evaluation will be performed after 72 hours, patients in UDCA will be evaluated will be on day 7. Patients with sufficient steroid response defined as ≥ 20% reduction in ALT, AST, ALP or bilirubin at day 4 or day 7 will undergo steroid tapering with a transition to peroral steroids. Patients with initial insufficient treatment response, defined as less than < 20% reduction in ALT, AST, ALP, or bilirubin, are considered as having a steroid-refractory condition and will be added MMF. In case of no response or increase of ALT, AST, ALP, or bilirubin during treatment with steroids plus MMF a third-line treatment may be introduced according to the individual treating hepatologist. Receives: Drug: Mycophenolate Mofetil; Drug: Solu-Medrol; Drug: Ursodeoxycholic acid; Drug: Prednisone tablet |
| Cohort B: Prednisolone versus MMF in steroiddependent ≥2 ir-hepatitis (randomized) | Active comparator | Patients who experienced relapse of ir-hepatitis of grade ≥2 during prednisolone tapering or within one months after ended tapering will be randomized to either 100% dose of current steroid dose or restart of steroid 0.5-1 mg/kg versus adding MMF (if the patient received prednisolone the tapering plan hereof is continued, prednisolone up to 25 mg can be added if clinical indicated). Treatment efficacy is evaluated after seven days, if sufficient response the patients continued treatment, in case of insufficient response a cross-over will be performed. Receives: Drug: Mycophenolate Mofetil; Drug: Ursodeoxycholic acid; Drug: Prednisone tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-assessed hepatitis response rates
Treatment-assessed hepatitis response rates with steroids and steroids plus either mycophenolate mofetil or tacrolimus
Measured: Through study completion, an average of 5 years
Time to response or downgrading of liver injury in days
Time to response or downgrading of liver injury in patients with ≥grade 3 ir-hepatitis measured as; Days to ≥20 percent reduction in liver specific transaminases (ALT/AST) or bilirubin Days to shift to peroral prednisolone and discharge
Measured: Until completion of the study, an average of 5 years
Secondary outcomes (7)
Relapse rate of immune related hepatitis ≥2 during tapering plan
Percent of patients with relapse to grade ≥2 hepatitis during steroid or during steroid plus either mycophenolate mofetil or tacrolimus tapering.
Measured: Through study completion, an average of 5 years
Time to downgrading of hepatotoxicity assessed by CTCAE v5.0
Time to downgrading of hepatotoxicity from grade 4 to grade 3, to grade 2 and to grade 1, respectively, assessed by CTCAE v5.0
Measured: Through study completion, an average of 5 years
Description of histopathological changes in liver tissue
Number of patients with hepatocellular, cholestatic and mixed liver injury respectively, assessed by histological findings of predominant injury to hepatocytes, bile ducts or combined.
Measured: Until completion of the study, an average of 5 years
Incidence of abnormal laboratory test results
Incidence of abnormal laboratory test results in blood
Measured: Until completion of the study, an average of 5 years
Cumulated doses of corticosteroids and MMF respectively
Cumulated doses of corticosteroids and MMF respectively, during the study period of 6 months
Measured: Until completion of the study, an average of 5 years
Cancer progression free survival at 6 months
Cancer progression free survival at 6 months
Measured: Until completion of the study, an average of 5 years
Overall survival rates at 6 months
Overall survival rates at 6 months
Measured: Until completion of the study, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start7 Apr 2021
- Primary completion7 Apr 2025 (estimated)
- Study completion7 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis, Drug-InducedStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- The aim is to enroll around 40 patients in Cohort A for prospectively characterize the various patterns of liver injury histopathologically, biochemically, and phenotypically that are induced by ICI, and the response to treatment (steroids and MMF). Cohort B: 20 patients who experienced a relapse of ir-hepatitis (grade ≥2) during prednisolone tapering or within one month after ended tapering will be randomized to either 100% dose of current steroid dose or restart of steroid 0.5-1 mg/kg versus adding MMF (if the patient received prednisolone the tapering plan hereof is continued, prednisolone up to 25 mg can be added if clinical indicated). Treatment efficacy is evaluated after seven days, if sufficient response the patients continued treatment, in case of insufficient response a cross-over will be performed
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inge Marie Svane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inge Marie Svane, Herlev Hospital
- Investigators
- Inge M Svane, Study director, Study Director, National Center for Cancer Immune Therapy, Dept. of Oncology, Hospital HerlevRikke B Holmstrøm, Principal investigator, Ph.D student, National Center for Cancer Immune Therapy, Dept. of Oncology, Hospital Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810156
- Sponsor's protocol ID
- AA2032
- Acronym
- I-HEP
- Status last verified
- Dec 2022
- First submitted
- 17 Mar 2021
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Holmstroem RB, Teisner AS, Sweep MWD, Noringriis IM, Khan S, Aagaard NK, Karlstrom J, Jurlander RS, Sohlin JE, Monberg TJ, Vestergaard C, Stoltenborg Granhoj J, Stenbog P, Toxvaerd A, Hansen AB, Bjerring PN, Lorentzen T, Thielsen P, Bol K, Jonsson G, Ellebaek E, Svane IM. Prospective study of patients with immune checkpoint inhibitor-induced hepatitis; characterization of liver injury, outcome of therapy, and management of steroid-unresponsive and steroid-dependent hepatitis. J Immunother Cancer. 2026 Mar 5;14(3):e013861. doi: 10.1136/jitc-2025-013861.
PubMed 41786454
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Prospective Study of Patients With Hepatitis Induced by Immune Checkpoint Inhibitors; Characterization of Liver Injury, Outcome of Therapy and Randomization to Either Prednisolone or Mycophenolate Mofetil Treatment in Case of Relapse
- ClinicalTrials.gov ID
- NCT04810156
- Acronym / sponsor ID
- I-HEP / AA2032
- Conditions
- Hepatitis, Drug-Induced
- Keywords
- Hepatitis, Immunotherapy, Cancer, Adverse events, Immune checkpoint inhibitors, Steroid-refractory, Steroid-dependent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inge Marie SvaneUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 7 Apr 2025 (estimated)
- Study completion
- 7 Nov 2025 (estimated)
- First posted
- 22 Mar 2021 (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.
This clinical trial is to clarify and investigate the patterns of immune-related hepatitis and the optimal treatment choice for patients who are steroid-dependent. The project aims to prospectively characterize the various histopathological, biochemical, and phenotypical liver injury patterns induced by immune checkpoint inhibitors and the treatment responses to corticosteroids. Furthermore, the effect of adding a second-line immunosuppressive drug, either MMF in steroid-refractory or steroid-dependent cases will be explored and compared.
Detailed description
The number of patients treated with immune checkpoint inhibitors (ICI) is expanding worldwide due to an increasing number of indications, including additional types of cancer, combination of ICI with other antineoplastic therapies and have recently moved into the adjuvant setting. According to clinical trial material, almost all patients in ICI treatment will eventually develop any grade of an adverse event, here, estimated in up to 90 percent of treated patients. Around 10-30 percent of ICI-treated patients will show signs of liver injury related to ICI treatment and will be diagnosed with immune-related hepatitis. The treatment hereof should include observation and medium-dose steroids in low-grade asymptomatic patients (grade ≤ 2 ir-hepatitis) and high-dose steroids in higher grades according to the current European and American guidelines. However, up to 25 percent of patients with ir-hepatitis may not respond properly to steroids due to primary resistance or relapse during tapering. These patients should be offered a second-line immunosuppressive treatment. The present recommendation for patients with steroid-dependent ir-hepatitis is based on the case series and includes immunosuppressive treatment with mycophenolate mofetil (MMF). To date, no evidence exists for which second-line treatment to choose.
However, in the clinic, the initiation of MMF may be delayed, meanwhile, patients are typically treated with an increased dose of steroids. In some cases, an increased dose of steroids with prolonged tapering can be sufficient. We want to explore if increased doses of steroids or adding MMF is the best strategy for relapse of hepatitis.
In addition, patients with signs of biliary or mixed liver injury may benefit from adding ursodeoxycholic acid (UDCA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The aim is to enroll around 40 patients in Cohort A for prospectively characterize the various patterns of liver injury histopathologically, biochemically, and phenotypically that are induced by ICI, and the response to treatment (steroids and MMF). Cohort B: 20 patients who experienced a relapse of ir-hepatitis (grade ≥2) during prednisolone tapering or within one month after ended tapering will be randomized to either 100% dose of current steroid dose or restart of steroid 0.5-1 mg/kg versus adding MMF (if the patient received prednisolone the tapering plan hereof is continued, prednisolone up to 25 mg can be added if clinical indicated). Treatment efficacy is evaluated after seven days, if sufficient response the patients continued treatment, in case of insufficient response a cross-over will be performed
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Steroids and MMF in grade 3-4 ir-hepatitis | Active comparator | Drug: Mycophenolate Mofetil, Drug: Solu-Medrol, Drug: Ursodeoxycholic acid, Drug: Prednisone tabletPatients with ≥ 3 grade ir-hepatitis will be treated with high-dose steroids 2 mg/kg/day intravenously. A diagnostic liver biopsy will be taken. Patients with mixed or cholestatic liver injury patterns will be added UDCA. Treatment evaluation will be performed after 72 hours, patients in UDCA will be evaluated will be on day 7. Patients with sufficient steroid response defined as ≥ 20% reduction in ALT, AST, ALP or bilirubin at day 4 or day 7 will undergo steroid tapering with a transition to peroral steroids. Patients with initial insufficient treatment response, defined as less than < 20% reduction in ALT, AST, ALP, or bilirubin, are considered as having a steroid-refractory condition and will be added MMF. In case of no response or increase of ALT, AST, ALP, or bilirubin during treatment with steroids plus MMF a third-line treatment may be introduced according to the individual treating hepatologist. |
| Cohort B: Prednisolone versus MMF in steroiddependent ≥2 ir-hepatitis (randomized) | Active comparator | Drug: Mycophenolate Mofetil, Drug: Ursodeoxycholic acid, Drug: Prednisone tabletPatients who experienced relapse of ir-hepatitis of grade ≥2 during prednisolone tapering or within one months after ended tapering will be randomized to either 100% dose of current steroid dose or restart of steroid 0.5-1 mg/kg versus adding MMF (if the patient received prednisolone the tapering plan hereof is continued, prednisolone up to 25 mg can be added if clinical indicated). Treatment efficacy is evaluated after seven days, if sufficient response the patients continued treatment, in case of insufficient response a cross-over will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Abnormal liver parameters equal to ≥ grade 3 ir-hepatitis defined as; AST/ALT/ALP >5 x ULN, INR ≥ 2.5 x ULN, or bilirubin > 3.0 x ULN
- Patients who recur during or within one months of prednisolone tapering of ≥2 ir-hepatitis equal to AST/ALT ≥3 x ULN, ALP ≥2.5 x ULN, INR ≥ 1.5 x ULN, or bilirubin ≥ 3.0 x ULN
- Cohort A and Cohort B
- Histologically confirmed solid cancer
- Treatment with cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) or Programmed Cell Death-1 (PD-1)/Programmed Cell Death Ligand-1 (PD-L1) inhibitor or a combination of CTLA-4 plus PD-1 inhibitors within 6 months
Key exclusion criteria (10 listed)
- Concomitant chemotherapy treatment or tyrosine kinases or angiogenesis inhibitors
- Concomitant immunosuppressive medication except prednisolone
- Patients with hepatocellular carcinoma
- Known hypersensitivity to one of the active drugs or excipients
- Uncontrolled infection
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 |
|---|---|---|
| Mycophenolate MofetilAlso: Cellcept, MyfenaxDay 1: MMF 500 mg twice a day Day 2: MMF 1000 mg twice a day | Drug | Cohort A: Steroids and MMF in grade 3-4 ir-hepatitis, Cohort B: Prednisolone versus MMF in steroiddependent ≥2 ir-hepatitis (randomized) |
| Solu-MedrolAlso: Methylprednisolone, Medrol, Corticosteroids, Steroid2 mg/kg/day | Drug | Cohort A: Steroids and MMF in grade 3-4 ir-hepatitis |
| Ursodeoxycholic acidAlso: ursocholPatients with mixed or cholestatic liver injury pattern will also be administrated peroral UDCA according to weight | Drug | Cohort A: Steroids and MMF in grade 3-4 ir-hepatitis, Cohort B: Prednisolone versus MMF in steroiddependent ≥2 ir-hepatitis (randomized) |
| Prednisone tabletAlso: steroid, CorticosteroidsShift from solu-medrol IV to peroral prednisolon. A tapering plan will be performed. | Drug | Cohort A: Steroids and MMF in grade 3-4 ir-hepatitis, Cohort B: Prednisolone versus MMF in steroiddependent ≥2 ir-hepatitis (randomized) |
Primary outcome
Treatment-assessed hepatitis response rates
Time frame: Through study completion, an average of 5 years
Treatment-assessed hepatitis response rates with steroids and steroids plus either mycophenolate mofetil or tacrolimus
Time to response or downgrading of liver injury in days
Time frame: Until completion of the study, an average of 5 years
Time to response or downgrading of liver injury in patients with ≥grade 3 ir-hepatitis measured as; Days to ≥20 percent reduction in liver specific transaminases (ALT/AST) or bilirubin Days to shift to peroral prednisolone and discharge
7 secondary outcomes
Relapse rate of immune related hepatitis ≥2 during tapering plan
Time frame: Through study completion, an average of 5 years
Time to downgrading of hepatotoxicity assessed by CTCAE v5.0
Time frame: Through study completion, an average of 5 years
Description of histopathological changes in liver tissue
Time frame: Until completion of the study, an average of 5 years
Incidence of abnormal laboratory test results
Time frame: Until completion of the study, an average of 5 years
Cumulated doses of corticosteroids and MMF respectively
Time frame: Until completion of the study, an average of 5 years
Cancer progression free survival at 6 months
Time frame: Until completion of the study, an average of 5 years
Overall survival rates at 6 months
Time frame: Until completion of the study, an average of 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Derived from this study: PubMed 41786454Holmstroem RB, Teisner AS, Sweep MWD, Noringriis IM, Khan S, Aagaard NK, Karlstrom J, Jurlander RS, Sohlin JE, Monberg TJ, Vestergaard C, Stoltenborg Granhoj J, Stenbog P, Toxvaerd A, Hansen AB, Bjerring PN, Lorentzen T, Thielsen P, Bol K, Jonsson G, Ellebaek E, Svane IM. Prospective study of patients with immune checkpoint inhibitor-induced hepatitis; characterization of liver injury, outcome of therapy, and management of steroid-unresponsive and steroid-dependent hepatitis. J Immunother Cancer. 2026 Mar 5;14(3):e013861. doi: 10.1136/jitc-2025-013861.
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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. This study is not recruiting at the moment.
Inge M Svane study director
Study Director, National Center for Cancer Immune Therapy, Dept. of Oncology, Hospital Herlev
Rikke B Holmstrøm principal investigator
Ph.D student, National Center for Cancer Immune Therapy, Dept. of Oncology, Hospital Herlev
5 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 Mycophenolate Mofetil, Solu-Medrol and Ursodeoxycholic acid in people with Hepatitis, Drug-Induced, run by Inge Marie Svane at 5 sites in Denmark.
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 12 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inge Marie Svane, M.D. Professor (+38683868, inge.marie.svane@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-assessed hepatitis response rates (time frame: Through study completion, an average of 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04810156, which also lists 1 linked publication.
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 14 Dec 2022.