An interventional study of Methylprednisolone and Magnesium isoglycyrrhizinate in Drug Induced Liver Injury, sponsored by General Hospital of Shenyang Military Region. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by General Hospital of Shenyang Military Region · Not applicable, Interventional, and Treatment
Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. However, the available evidence remains controversial and its quality is also very limited. Herein, a multicenter randomized controlled trial (RCT) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute DILI and hyperbilirubinemia.
Overall, 232 patients with acute DILI with hyperbilirubinemia will be enrolled. They will be randomly assigned at a ratio of 1:1 to the conventional treatment alone or combined with glucocorticoids groups. The primary endpoint is the improvement of DILI after treatment on second week. Secondary endpoints include the improvement of DILI on fourth week, rates of progressive liver injury, liver failure, liver transplantation, survival, and adverse events. Exploratory endpoints will assess the beneficial population and changes of inflammatory factors following glucocorticoid treatment.
80 studies on the registry are indexed under Chemical and Drug Induced Liver Injury; 21 are open to participants now.
This study's planned enrollment of 232 is above the median of 80 across 40 interventional studies indexed under Chemical and Drug Induced Liver Injury.
Browse Chemical and Drug Induced Liver Injury studies →General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Glucocorticoids step-down therapy combined with conventional treatment.
Drug: Methylprednisolone · Drug: Magnesium isoglycyrrhizinate · Drug: Glutathione · Drug: Silymarin · Drug: Polyene Phosphatidylcholine · Drug: Ursodeoxycholic acid capsules · Drug: Ademetionine 1,4-Butanedisulfonate · Procedure: Plaslna exchange · Procedure: Liver transplantation
Only conventional treatment according to the Chinese practice guidelines regarding the management of DILI.
Drug: Magnesium isoglycyrrhizinate · Drug: Glutathione · Drug: Silymarin · Drug: Polyene Phosphatidylcholine · Drug: Ursodeoxycholic acid capsules · Drug: Ademetionine 1,4-Butanedisulfonate · Procedure: Plaslna exchange · Procedure: Liver transplantation
Initially, an intravenous dose of 1 mg/kg/day of methylprednisolone will be administered for one week, with the possibility of extending treatment to two weeks if necessary. Following this, participants will receive oral methylprednisolone tablets, starting at a dose of 40 mg/day. The oral dosage will be gradually tapered based on the participants' condition over a period of 1 to 3 months.
Also known as: Medrol
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 0.15g to 0.2g
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 140 mg, taken 2 to 3 times per day.
Also known as: Legalon
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 228mg-456mg, taken 3 times per day.
Also known as: Essentiale
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 10mg-15mg/kg/day.
Also known as: Ursofalk
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 0.5g to 1g.
Also known as: Transmeti
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
Also known as: Artificial liver support
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
Improvement of DILI on the second week
TBIL level decreases by 50% as compared to the baseline level.
Time frame: 2 weeks
Improvement of DILI on the fourth week
TBIL level decreases by 50% as compared to the baseline level.
Time frame: 4 weeks
Progressive liver injury on the second week
TBIL level increases as compared to the baseline level.
Time frame: 2 weeks
Progressive liver injury on the fourth week
TBIL level increases as compared to the baseline level.
Time frame: 4 weeks
Improvement of liver enzymes on the second week
Proportion of 50% reduction from baseline in ALT, AST, ALP, and GGT levels.
Time frame: 2 weeks
Improvement of liver enzymes on the fourth week
Proportion of 50% reduction from baseline in ALT, AST, ALP, and GGT levels.
Time frame: 4 weeks
Liver failure
Participants develop overt hepatic encephalopathy with an INR of ≥1.5.
Time frame: 3 months
Liver transplantation
Participants undergo liver transplantation due to liver failure.
Time frame: 3 months
Survival
All participants will be followed by telephone to record survival status, including the major cause and date of death.
Time frame: 3 months
Adverse events
Adverse events related to glucocorticoids mainly include infection, water-sodium retention, Cushing syndrome, poor glycemic, gastrointestinal ulcer, thromboembolic disease, neuropsychiatric symptoms, osteoporosis, increased intraocular pressure, and withdrawal syndrome. They will be closely recorded during the period of glucocorticoids treatment.
Time frame: 3 months
Population who will be more suitable for glucocorticoids treatment
Characteristics of patients with DILI in whom glucocorticoids treatment is more beneficial.
Time frame: 3 months
Changes of inflammatory factors
Changes of IL-6 and TNF-α levels.
Time frame: 4 weeks
Plan to share: No
Started Jun 2025 (actual). Primary completion is estimated for Mar 2027, 21 months after the start.
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Chemical and Drug Induced Liver Injury →
General Hospital of Shenyang Military Region