Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
NCT ID: NCT06922669
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
232 participants
INTERVENTIONAL
2025-06-24
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glucocorticoids group
Glucocorticoids step-down therapy combined with conventional treatment.
Methylprednisolone
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.
Magnesium isoglycyrrhizinate
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 0.15g to 0.2g
Glutathione
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g
Silymarin
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 140 mg, taken 2 to 3 times per day.
Polyene Phosphatidylcholine
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 228mg-456mg, taken 3 times per day.
Ursodeoxycholic acid capsules
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 10mg-15mg/kg/day.
Ademetionine 1,4-Butanedisulfonate
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 0.5g to 1g.
Plaslna exchange
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
Liver transplantation
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
Conventional treatment
Only conventional treatment according to the Chinese practice guidelines regarding the management of DILI.
Magnesium isoglycyrrhizinate
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 0.15g to 0.2g
Glutathione
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g
Silymarin
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 140 mg, taken 2 to 3 times per day.
Polyene Phosphatidylcholine
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 228mg-456mg, taken 3 times per day.
Ursodeoxycholic acid capsules
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 10mg-15mg/kg/day.
Ademetionine 1,4-Butanedisulfonate
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 0.5g to 1g.
Plaslna exchange
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
Liver transplantation
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
Interventions
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Methylprednisolone
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.
Magnesium isoglycyrrhizinate
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 0.15g to 0.2g
Glutathione
It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g
Silymarin
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 140 mg, taken 2 to 3 times per day.
Polyene Phosphatidylcholine
It is suitable for patients with hepatocellular or mixed DILI. The dosage is 228mg-456mg, taken 3 times per day.
Ursodeoxycholic acid capsules
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 10mg-15mg/kg/day.
Ademetionine 1,4-Butanedisulfonate
It is suitable for patients with cholestatic or mixed DILI. A daily dose of 0.5g to 1g.
Plaslna exchange
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
Liver transplantation
It is suitable for patients whose condition continues to worsen or even develop to liver failure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 5×ULN ≤ TBIL level at baseline ≤ 20×ULN;
* Age 18-80 years old;
* Sign the informed consent form.
Exclusion Criteria
* Immune checkpoint inhibitors or gynura segetum induced DILI;
* Absolute contraindications to glucocorticoids, such as systemic mold infections or allergies;
* A history of glucocorticoid therapy within 3 months before enrollment;
* A history of diseases requiring glucocorticoid maintenance therapy, such as rheumatoid arthritis, systemic lupus erythematosus, systemic dermatomyositis, etc;
* A history of liver transplantation;
* Received artificial liver therapy before enrollment;
* Malignant tumor of the liver, bile duct, pancreas or liver metastasis
* Acute liver failure;
* Renal dysfunction, creatinine Cr≥133μmol/L;
* Neutrophil count \<1,000,000,000/L;
* Active tuberculosis;
* Severe cardiopulmonary diseases;
* Recent surgery or trauma;
* Mental illness;
* Pregnancy or lactation;
* Participated in other clinical studies within 3 months before enrollment;
* Other conditions judged by the clinician to be inappropriate for study participation.
18 Years
80 Years
ALL
No
Sponsors
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General Hospital of Shenyang Military Region
OTHER
Responsible Party
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Xingshun Qi
Director of Department of Gastroenterology
Principal Investigators
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Xingshun Qi
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, General Hospital of Northern Theater Command
Weifen Xie
Role: PRINCIPAL_INVESTIGATOR
Shanghai changzheng hospital, Naval Medical University
Xin Zeng
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital,Tongji University School of Medicine
Lu Zhou
Role: PRINCIPAL_INVESTIGATOR
General Hospital, Tianjin Medical University
Fengmei Wang
Role: PRINCIPAL_INVESTIGATOR
Tianjin First Central Hospital
Qing Ye
Role: PRINCIPAL_INVESTIGATOR
Tianjin Third Central Hospital
Yanjing Gao
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital of Shandong University
Locations
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Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Xingshun Qi
Role: primary
Qianqian Li
Role: backup
References
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Hou FQ, Zeng Z, Wang GQ. Hospital admissions for drug-induced liver injury: clinical features, therapy, and outcomes. Cell Biochem Biophys. 2012 Nov;64(2):77-83. doi: 10.1007/s12013-012-9373-y.
Hu PF, Wang PQ, Chen H, Hu XF, Xie QP, Shi J, Lin L, Xie WF. Beneficial effect of corticosteroids for patients with severe drug-induced liver injury. J Dig Dis. 2016 Sep;17(9):618-627. doi: 10.1111/1751-2980.12383.
Chai L, Wang R, Teschke R, Jin S, Deng J, Qi X. Successful corticosteroid therapy for severe liver injury secondary to herbal traditional Chinese medicine, Mega Defends X, assessed for causality by the updated RUCAM: A case report. Medicine (Baltimore). 2024 Aug 23;103(34):e39439. doi: 10.1097/MD.0000000000039439.
Mao Y, Ma S, Liu C, Liu X, Su M, Li D, Li Y, Chen G, Chen J, Chen J, Zhao J, Guo X, Tang J, Zhuge Y, Xie Q, Xie W, Lai R, Cai D, Cai Q, Zhi Y, Li X; Technology Committee on DILI Prevention, Management, Chinese Medical Biotechnology Association; Study Group on Drug-Induced Liver Disease, Chinese Society of Hepatology, Chinese Medical Association. Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update. Hepatol Int. 2024 Apr;18(2):384-419. doi: 10.1007/s12072-023-10633-7. Epub 2024 Feb 24.
Other Identifiers
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XHNKKY-ASDILI-RCT
Identifier Type: -
Identifier Source: org_study_id