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Can steroids rescue livers damaged by medications?

NCT ID NCT06922669

Disease control Sponsor: General Hospital of Shenyang Military Region Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a steroid drug (methylprednisolone) can help people with severe liver injury caused by medications. The trial includes 232 adults with high bilirubin levels. Participants receive either steroids plus standard care or standard care alone, and doctors track liver recovery over weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methylprednisolone (a steroid drug)
What this could lead to
If it works, this could provide a standard treatment for severe drug-induced liver injury with high bilirubin, potentially preventing liver failure.
What could go wrong
This is a mid-stage trial with 232 participants, so results may not apply to everyone. Steroids have side effects like infection risk and may not help all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 232 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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. Exclusion Criteria: * 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 disease, Budd-Chiari syndrome, biliary tract disease, Wilson's disease, hemochromatosis, and α1-antitrypsin deficiency; * 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.

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Conditions

The condition(s) this trial relates to.

drug-induced liver injury hyperbilirubinemia liver failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Drug-induced liver injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

    RECRUITING

    Shenyang, Liaoning, 110840, China

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