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New treatment option for Drug Induced Liver Injury
Official title Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
ClinicalTrials.gov ID: NCT06922669
What this study is testing
What is Methylprednisolone?
Methylprednisolone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for drug induced liver injury.
Also referred to as Medrol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- A definite diagnosis of acute DILI;
- 5×ULN ≤ TBIL level at baseline ≤ 20×ULN;
- Age 18-80 years old;
- Sign the informed consent form.
You likely can't join if
- Other causes of liver injury, including viral hepatitis, cytomegalovirus infection, Epstein-Barr virus infection, Herpes virus infection, autoimmune...
- 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...
- A history of liver transplantation;
See the full eligibility criteria
- A definite diagnosis of acute DILI;
- 5×ULN ≤ TBIL level at baseline ≤ 20×ULN;
- Age 18-80 years old;
- Sign the informed consent form.
- Other causes of liver injury, including viral hepatitis, cytomegalovirus infection, Epstein-Barr virus infection, Herpes virus infection, autoimmune liver disease, alcoholic liver disease, hypoxic/ischemic liver...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.