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New study aims to predict liver injury outcomes in thousands of patients

NCT ID NCT05060289

Knowledge-focused Sponsor: Beijing Friendship Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study will follow 3000 people in China who have drug-induced liver injury (DILI) to understand what factors affect their recovery. Researchers will collect blood samples and health data to create a model that predicts serious outcomes like liver failure or death. The goal is to improve how doctors manage DILI and identify patients who need closer monitoring.

What this could mean

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

What this could lead to
If successful, this could lead to a tool that helps doctors better predict who will recover or need a liver transplant after drug-induced liver injury.
What could go wrong
This is an observational study, not a treatment trial. The model may not work for all patients or be ready for use for many years.

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.

Participants

About 3,000 people

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

Started

May 2022

Expected to finish

Dec 2028

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.

Who is studied

Adult with drug-induced liver injury

Ages

18 years and older

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: 1. RUCAM ≥6 and met one of the following biochemical conditions: (1) ALT≥5 ULN, (2) or ALP ≥2 ULN, (3) or ALT≥3 ULN and TBil≥2 ULN. 2. RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis. 3. Onset to enrollment ≤3 months. Exclusion Criteria: 1. Hepatotropic viral infection: hepatitis A, B, C, D and E. 2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc. 3. Hypoxic ischemic hepatitis and congestive liver disease. 4. Alcohol consumption: male \>40g/d, female \>20g/d, and ≥5 years. 5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis. 6. Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG) simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment. 7. Parasitic infection. 8. Sepsis. 9. Previous liver transplantation or bone marrow transplantation. 10. Pregnancy or lactation. 11. Genetic and metabolic liver diseases.

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Conditions

The condition(s) this trial relates to.

drug-induced liver injury

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

    9 sites. 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

  • Beijing 302 Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100166, China

  • Beijing Ditan Hospital

    ACTIVE_NOT_RECRUITING

    Beijing, 100102, China

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, 100050, China

  • Beijing You 'an Hospital, Capital Medical University

    RECRUITING

    Beijing, 100069, China

  • Hebei CNPC Central Hospital

    ACTIVE_NOT_RECRUITING

    Hebei, 050011, China

  • Jiaozuo People's Hospital

    RECRUITING

    Jiaozuo, 454002, China

  • Peking University Third Hospital

    ACTIVE_NOT_RECRUITING

    Beijing, 100191, China

  • Qinghai People's Hospital

    RECRUITING

    Qinghai, 810007, China

  • Qinzhou First People's Hospital

    ACTIVE_NOT_RECRUITING

    Guangxi, 535009, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, 266003, China

  • The Second Affiliated Hospital of Dalian Medical University

    RECRUITING

    Dalian, 116023, China

  • The Second Hospital of Lanzhou University

    RECRUITING

    Lanzhou, 730046, China

  • Yuncheng Central Hospital

    RECRUITING

    Yuncheng, 044099, China

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